Zenocutuzumab-zbco

Active Organization

Inactive Organization-

License Organization

Adenocarcinoma of pancreas with NRG1 fusionNRG1 Fusion Positive non-small cell lung cancer

Drug Highest PhaseApproved

First Approval Date

United States (04 Dec 2024),

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Commissioner's National Priority Voucher (United States), Priority Review (United States)

Structure/Sequence

Sequence Code 43197L

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Sequence Code 26101535H

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Sequence Code 315583329H

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Clinical Trials associated with Zenocutuzumab-zbco

NCT05588609

/ TerminatedPhase 2

A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers

This is a Phase II, open-label, 2-arm, multicenter, international study designed to evaluate the efficacy of zenocutuzumab alone or in combination in patients with the following diagnoses:
Group A: NRG1+ NSCLC Group B: mCRPC

Start Date17 Nov 2022

Sponsor / Collaborator

NCT03321981

/ CompletedPhase 2

Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC

A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2).
Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet.
The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet.
In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

Start Date15 Jan 2018

Sponsor / Collaborator

NCT02912949

/ Active, not recruitingPhase 2

A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)

Start Date01 Jan 2015

Sponsor / Collaborator

Partner Therapeutics Announces Publication of Results From the eNRGy Trial of Zenocutuzumab in Patients with NRG1+ Cholangiocarcinoma in Journal of Clinical Oncology (JCO)

100 Clinical Results associated with Zenocutuzumab-zbco

100 Translational Medicine associated with Zenocutuzumab-zbco

100 Patents (Medical) associated with Zenocutuzumab-zbco

Literatures (Medical) associated with Zenocutuzumab-zbco

01 May 2026·JNCI-Journal of the National Cancer Institute

NRG1 fusion-positive solid tumors: clinical detection, genomic landscape, and real-world data in pancreatic cancer

Article

Author: Tarcan, Zeynep ; Ladanyi, Marc ; Yang, Soo-Ryum ; Sukhadia, Purvil ; Harding, James J ; O’Reilly, Eileen M ; Troxel, Megan ; Ozcan, Kerem ; Drilon, Alexander ; Kinh Gian Do, Richard ; Basturk, Olca ; Kahn, Genessa ; Schram, Alison M ; DiNapoli, Sara ; Velasco, Rogelio ; Repetto, Matteo

Abstract:

Background:

NRG1 fusions are unique oncogenic drivers that activate the HER3/HER2/PI3K pathway. The US Food and Drug Administration granted accelerated approval to a HER2/HER3 antibody, zenocutuzumab, for treatment of NRG1 fusion-positive non–small cell lung cancer and pancreatic ductal adenocarcinoma (PDAC). The optimal detection methods and clinicopathological features of patients with NRG1 fusion-positive cancer have not been systematically studied. Here, we review NRG1 fusion-positive cancer and focus on outcomes in PDAC.

Methods:

Patients with NRG1 fusion-positive disease at Memorial Sloan Kettering Cancer Center were identified using institutional databases. Clinicopathological data were extracted from medical records. NRG1 fusion-positive PDAC cases underwent review of radiology, pathology, treatment data, and assessment of progression-free and overall survival.

Results:

Of 76 531 patients, 48 NRG1 fusion-positive cases were identified. The most common tumor types were lung (60%), PDAC (21%), and breast (10%). Approximately half (46%) of these patients received HER2- and/or HER3-directed therapy. Patients were identified by RNA (n = 34), DNA (n = 11), or both (n = 3). RNA was superior to DNA for fusion identification. Twenty-one fusion partners were detected, most commonly CD74 (40%) and ATP1B1 (10%). Lung cancers were otherwise driver negative, and PDAC cases were KRAS wild type. NRG1 fusion-positive PDAC exhibited distinct histopathological and clinical features. Median patient age was 48.5 years, median progression-free survival on first-line chemotherapy was 12.6 months (n = 7; 95% confidence interval [CI] = 2.9 to not reached), and median overall survival from diagnosis was 39.6 months (n = 9; 95% CI = 23.2 to not reached).

Conclusions:

NRG1 fusions are a newly described, clinically actionable target in solid tumors. We report the landscape of NRG1 fusion-positive cancers and highlight the importance of RNA testing. NRG1 fusion-positive PDAC is enriched in younger patients with KRAS wild-type disease and has unique biology.

02 Apr 2026·MOLECULAR CANCER THERAPEUTICS

Article

Author: Mao, Ninghui ; Chang, Qing ; de Stanchina, Elisa ; Carver, Brett S. ; Salsabeel, Nazifa ; Lee, Young Sun ; Shinder, Brian M. ; Chen, Xiaoping ; Gopalan, Anuradha ; Sawyers, Charles L. ; Kaur, Harmanpreet ; Zhang, Zeda

Abstract:

Investigating the mechanisms of acquired resistance to antiandrogens remains a critical clinical need as patients with prostate cancer inevitably develop resistance to androgen receptor (AR)–targeted therapies. Previously, we demonstrated that neuregulin 1 (NRG1) derived from cancer-associated fibroblasts (CAF) promotes antiandrogen resistance through human epidermal growth factor receptor 3 (HER3)–AKT signaling. In this study, we sought to further dissect the molecular context in which NRG1-induced PI3K signaling activation plays a dominant role in driving resistance and evaluate whether targeting HER2/3 dimerization can influence sensitivity to AR inhibition. IHC analysis of radical prostatectomy specimens from patients with prostate cancer treated with or without neoadjuvant hormonal therapy shows that NRG1 was significantly upregulated following AR inhibition, independent of PTEN status. However, we found that stimulation with recombinant NRG1 or CAF-conditioned media induced resistance to AR inhibition only in PTEN wild-type prostate cancer cells and not in PTEN-deficient cells. Selective inhibition of NRG1 using the clinical-grade bispecific humanized immunoglobulin G1, zenocutuzumab (Zeno, MCLA-128), restored sensitivity to AR-targeted therapies in PTEN wild-type tumors, demonstrating its efficacy as a potential therapeutic agent to block the effects of NRG1. In the context of PTEN loss and AR inhibitor resistance, Zeno did not restore sensitivity. These findings highlight the critical molecular context in which tumor microenvironment–derived NRG1 affects responsiveness to AR inhibition and suggest that targeting NRG1 is a promising strategy for overcoming resistance to androgen blockade in PTEN wild-type prostate cancers.

01 Feb 2026·IEEE Transactions on Cybernetics

Article

Author: Zeng, Ze-Hong ; Wang, Yan-Wu ; Xiao, Jiang-Wen ; Liu, Xiao-Kang

This article investigates the event-triggered composite control problem for switched two-time-scale systems (TTSSs). First, the stabilization problem of switched TTSSs under switching composite control is addressed. Unlike existing results that require the singular perturbation parameter (SPP) to be sufficiently small or to satisfy specific linear matrix inequality conditions, an explicit upper bound of the SPP is derived. Then, both SPP-dependent and SPP-independent dynamic event-triggered mechanisms are developed to reduce the computational burden associated with control signal updates in switched TTSSs. These mechanisms are novel in that they incorporate the boundary layer system and explicitly balance the fast and slow time-scale dynamics. Furthermore, two sufficient stability conditions are established: one concerning the upper bound of the SPP and the other concerning the mode-dependent average dwell time, ensuring the stability of switched TTSSs under the respective mechanisms. In addition, Zeno's behavior is excluded in both cases. Finally, three numerical examples, including a comparative study, are provided to demonstrate the effectiveness and advantages of the proposed results.

News (Medical) associated with Zenocutuzumab-zbco

02 Jul 2026

·www.prnewswire.com

Zenocutuzumab offers meaningful and durable antitumor activity, substantially reduced toxicity and no treatment‑limiting safety concerns, distinguishing it favorably from existing standards of care LEXINGTON, Mass., July 2, 2026 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced that results from the cholangiocarcinoma cohort of the eNRGy trial (NCT02912949) have been published in the Journal of Clinical Oncology (JCO).1 These data supported the recent U.S. Food and Drug Administration (FDA) approval of BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. The approval was expedited by PTx's receipt of a Commissioner's National Priority Voucher (CNPV) underscoring the urgent unmet need in this patient population. "The FDA approval of BIZENGRI and the publication of these data in the Journal of Clinical Oncology highlight the clinical relevance of the eNRGy trial and reinforces our commitment to advancing therapies for patients with unmet medical needs, including those with NRG1 fusion-positive cholangiocarcinoma. The JCO publication further supports the therapeutic potential of zenocutuzumab in this rare population, which has historically experienced limited treatment options and poor outcomes with chemotherapy." — Fiona Garner, Executive Director, Clinical Development, Partner Therapeutics Data in NRG1 + Cholangiocarcinoma The eNRGy trial is a multicenter, open-label, phase 2 study evaluating zenocutuzumab in adults with advanced solid tumors harboring NRG1 gene fusions. Data published in JCO include 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma, of whom 19 were evaluable for efficacy. Most patients were pre-treated, with a median of one prior line of therapy (range up to 6). Notably, RNA-based next-generation sequencing (NGS) identified 100% of NRG1 fusions, compared with 29% detected by DNA-based testing. The investigator-assessed overall response rate (ORR), defined as the proportion of patients with tumor shrinkage or disappearance, was 36.8%. Median duration of response was 7.4 months, and median progression-free survival was 9.2 months. The clinical benefit rate was 57.9%, defined as the percentage of patients achieving a complete or partial response or stable disease lasting longer than 6 months. Zenocutuzumab was generally well tolerated. Most treatment-related adverse events were grade 1-2, with diarrhea (27.3%), fatigue (18.2%), and nausea (13.6%) being reported most frequently. No patients discontinued treatment due to treatment-related adverse events. "The FDA approval of zenocutuzumab and the publication of these data represent important progress for patients with NRG1 fusion–positive cholangiocarcinoma. Limited efficacy and poor tolerability of second-line chemotherapy remain a significant clinical challenge in the treatment of patients with advanced cholangiocarcinoma. Zenocutuzumab provided meaningful tumor responses, durable clinical benefit, and a favorable tolerability profile. These findings also underscore the critical importance of comprehensive molecular testing—particularly tissue-based RNA sequencing—to reliably identify NRG1 gene fusions and ensure patients are matched with appropriate targeted therapy." — James M. Cleary, MD, PhD, Director, Clinical Research, Division of Gastrointestinal Oncology, Dana-Farber Cancer Institute; and senior author. FDA Approval in Three NRG1 + Solid Tumors BIZENGRI was first FDA approved under accelerated approval in 2024 for advanced, unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma for patients harboring an NRG1 gene fusion on or after systemic therapy. In May 2026, BIZENGRI received FDA approval for advanced, unresectable or metastatic cholangiocarcinoma for patients harboring an NRG1 gene fusion on or after systemic therapy. Additionally, zenocutuzumab is included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for non-small cell lung cancer, pancreatic adenocarcinoma, and cholangiocarcinoma. For more information on the eNRGy trial and zenocutuzumab-zbco, please visit . About NRG1 + Cholangiocarcinoma Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with an all-stage 5-year overall survival of less than 15%. NRG1 gene fusions occur in fewer than 1% of cholangiocarcinoma cases. NRG1 fusions typically occur in patients who are otherwise driver negative, leaving affected patients, many of whom are younger adults, without approved targeted therapy. Standard cytotoxic regimens carry substantial toxicity, and second-line options such as FOLFOX produce objective responses in only approximately 5% of patients. About NRG1 Gene Fusions NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activating downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1. About BIZENGRI (zenocutuzumab-zbco) INDICATIONS BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.* BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.* BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Important Safety Information BOXED WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception. WARNINGS AND PRECAUTIONS Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough. In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion. Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions. Interstitial Lung Disease/Pneumonitis BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis. In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated. Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed. Left Ventricular Dysfunction BIZENGRI can cause left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment. In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event. Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI. Embryo-Fetal Toxicity Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose. ADVERSE REACTIONS NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI (n=99). Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each). In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27%), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transferase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%). NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI (n=39). There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure. In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transferase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%). NRG1 Gene Fusion Positive Advanced, Unresectable or Metastatic Cholangiocarcinoma Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI (n=22). In patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased magnesium (59%), increased alanine aminotransferase (50%), fatigue (46%), decreased platelets (46%), decreased hemoglobin (41%), increased aspartate aminotransferase (41%), increased alkaline phosphatase (41%), decreased phosphate (41%), diarrhea (41%), abdominal pain (36%), musculoskeletal pain (36%), increased gamma-glutamyl transferase (36%), increased bilirubin (32%), decreased potassium (32%), decreased sodium (32%), nausea (27%), cough (27%), increased activated partial thromboplastin time (aPTT) (27%), dyspnea (23%), decreased appetite (23%), and decreased albumin (23%). Please see full Prescribing Information, including BOXED WARNING. About Partner Therapeutics Partner Therapeutics, Inc. (PTx), an integrated biotechnology company, focuses on development and commercialization of therapeutics to improve health outcomes in cancer and serious diseases, as well as global health security threats. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. PTx's portfolio includes zenocutuzumab-zbco (BIZENGRI®) and sargramostim (US: LEUKINE®; EU: IMREPLYS®; and with Nobelpharma Co. Ltd for JAPAN: SARGMALIN®). Visit . Reference: 1. Cleary JM, Springfeld C, Arnold D, et al. Efficacy and tolerability of zenocutuzumab in advanced NRG1 fusion-positive cholangiocarcinoma: Results from the eNRGy phase 2 trial. J Clin Oncol. 2026. doi:10.1200/JCO-25-03128 NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. BIZENGRI® is a registered trademark of Merus B.V., a wholly owned subsidiary of Genmab A/S. Under an agreement with Merus, PTx has exclusive rights to develop, manufacture, and commercialize zenocutuzumab-zbco for the treatment of NRG1+ cancer in the U.S. and provide the product on a named-patient basis for this use outside of the U.S. pending future regulatory developments. PARTNER THERAPEUTICS®, LEUKINE®, and IMREPLYS® are registered trademarks owned by Partner Therapeutics, Inc. ©2026 Partner Therapeutics, All rights reserved. SOURCE Partner Therapeutics, Inc. 21% more press release views with Request a Demo

Clinical ResultLicense out/inDrug ApprovalPhase 2Accelerated Approval

05 Jun 2026

·www.fiercebiotech.com

At first public hearing for FDA’s CNPV program, industry support meets ‘deep concern’ from experts

Peter Lurie, M.D., a former FDA official and current president and executive director of the Center for Science in the Public Interest, urged the agency to end the CNPV program.\n On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National Priority Voucher (CNPV) pilot program, the flagship initiative of recently departed agency leader Marty Makary, M.D. Comments at the June 4 public hearing largely fell along three main fault lines—industry voiced general support for the program; physicians and public health experts expressed concerns; and patient advocates pressed for vouchers to be given to promising treatments for their diseases of interest.The hearing was moderated by Dayle Cristinzio, the FDA’s director of public engagement, with the most prominent agency attendees including Michael Davis, M.D., Ph.D., the current acting head of the Center for Drug Evaluation and Research (CDER) and Mallika Mundkur, M.D., deputy chief medical officer.Though the hearing is now over, the public can still comment on the CNPV pilot until midnight on June 29. Public feedback, Mundkur said, will “directly inform how FDA evaluates the program\'s future.”Mundkur started the hearing by outlining the CNPV review process, which includes a 60-day pre-submission period followed by a two-to-three-week window in which the sponsor can file for approval and the application is checked for completeness. After that, the goal is to review the application in one or two months.The biggest industry players represented at the hearing were Johnson & Johnson and Merck & Co., which both expressed support for the program, and have received vouchers through it.“Our experience reflected a highly collaborative review process with close engagement between FDA and J&J,” Ginny Beakes-Read, J&J’s head of global regulatory policy, said during the hearing. As the first speaker of the event, Beakes-Read highlighted the voucher awarded to J&J’s multiple myeloma medicine Tecvayli, which was proactively granted by the FDA in December 2025 and not sought after by the Big Pharma. The voucher resulted in a speedy approval for Tecvayli in combination with Darzalex Faspro in March.While lauding the agency’s close collaboration with J&J during the Tecvayli review, Beakes-Read noted that a more structured review process with clearer expectations around communication would be good for the program moving forward. She also expressed a desire for high-level feedback from the CNPV review council, to “help sponsors understand and address issues identified by the council.”Merck, too, shared some suggested tweaks to the program, drawing on its own experience of being granted two vouchers. One of these was for its PCSK9 inhibitor enlicitide decanoate and another for the TROP2-targeting antibody-drug conjugate commonly known as sac-TMT.“In our experience, success in the pilot has come through earlier structured scientific engagement with the review team that aids with early alignment on strategy and data requirements, particularly in CMC, while ensuring regulatory rigor,” Ashley Wivel, M.D., Merck’s vice president of global regulatory affairs, said during the hearing.Overall, the New Jersey drugmaker is “supportive of the CNPV pilot, and Merck is supportive of the FDA’s goal of accelerating access through well-prepared, high-quality submissions,” Wivel said.Meanwhile, Partner Therapeutics also used the hearing to share its gratitude to the CNPV program, which led to the approval of its cancer medicine Bizengri in cholangiocarcinoma. “The CNPV program accelerated FDA review time from 10 months to six weeks, streamlining access to this small patient population with significant unmet need,” Partner’s chief technology officer Debasish Roychowdhury, M.D., told the audience. “Drug development is a complex and difficult endeavor, and when the scientists, physicians and healthcare providers, as well as regulators and sponsors, work together, magic happens,” Roychowdhury said. “In this case, the CNPV was the magic wand.” The opposition Not all the speakers at the hearing viewed the CNPV program as a near-mythical tool to hasten drug development. Others took to the lectern to align themselves with past criticisms from lawmakers, medical ethicists and former CDER director Richard Pazdur, M.D.The harshest words came from Peter Lurie, M.D., the president and executive director of the Center for Science in the Public Interest, who himself spent just under eight years at the FDA.“We encourage the agency to wind down this pilot,” Lurie said. “Given our concerns about politicization in voucher selection and review, strained agency resources and lack of transparency.”As examples of politicization, Lurie highlighted the recent granting of vouchers to three psychedelic biotechs on President Trump’s orders, which apparently followed a text exchange between the president and podcaster Joe Rogan. “There\'s a taint here of political involvement, and none of them have to do with the safety and effectiveness criteria, which are the actual criteria for drug approval,” Lurie said.He also pointed to the structure of the CNPV review council, as outlined in a staff manual guide (PDF), which includes the FDA commissioner, agency center directors and other senior leadership.“Although the guide says that the commissioner will not vote on discussions related to approvability, as the chair of the council, he or she is likely to exert heavy influence over the council\'s recommendations,” Lurie explained. “Almost everyone else on the council is likely to be a political appointee in marked contrast to FDA historical practices, which went to great lengths to insulate drug review from inappropriate political intervention.”“We urge the agency to set up career scientists and subject matter experts in the approval process to ensure the drug approvals are guided by science and not by politics,” he added.Lurie also lambasted the agency’s lack of transparency over why certain companies receive vouchers, noting that some of the national priorities outlined by the program—like drug pricing and domestic manufacturing—fall outside the FDA’s purview. “Of the 22 drugs so far awarded vouchers through the program, 10 are marketed by companies that have made deals with the White House on drug pricing,” he said.Janet Krommes, M.D., the head of the FDA task force at Doctors for America, also expressed her organization\'s “deep concerns” about the CNPV program. Notably, the fact that the CNPV was unveiled through a journal publication and press release rather than through normal administrative procedures or an act of Congress “opens up the entire FDA to questions about whether their process is going to be fair and open.”“The ambiguity of the criteria in this context and lack of transparency has given life to rumors about political influences determining winners and losers,” Krommes said. “This is extremely corrosive to patient care.”Scholars agreed that the program, as currently constructed, could pose a risk to the public’s trust in the FDA and urged it to be formalized through normal procedures. “I strongly encourage [the] FDA to prioritize the development of notes and comment rules or guidance that would put the program on strong footing and help deliver benefits to American patients,” Lowell Schiller, a nonresident senior scholar at the USC Schaeffer Institute and former FDA official, said during the hearing.“Although FDA decisions have long been trusted, both in the U.S. and internationally, for their scientific rigor and their independence, the CNPV pilot program has serious flaws that could undermine that trust,” Thomas Hwang, M.D., of Harvard Medical School and Brigham and Women’s Hospital, added. Public appeals The third category of comments heard at the hearing came from patient advocates for various diseases, who pressed the FDA to include patient voices in the program and grant vouchers to potential breakthrough medicines.Kristen Wheeden, president of the United Porphyrias Association, described the “crushing blow” of the FDA’s rejection of Disc Medicine’s drug candidate for the rare disease, which received a CNPV voucher only to later be denied approval.“I ask today, what needs to change in the Commissioner\'s National Priority review Voucher process to ensure that it is fair, equitable, transparent and meaningfully informed by the patient voice?” Wheeden said.Two advocates for Huntington’s disease, which was recently ensnared in controversy due to the FDA’s handling of a gene therapy from uniQure, asked that the agency consider granting vouchers to breakthrough therapies for the devastating progressive condition.“Life-changing therapies for HD are a strong fit for the Commissioner\'s National Priority Voucher pilot program,” Huntington’s advocate Christina DeGryse said. “For families like mine, time matters.”

Drug Approval

28 May 2026

·allsci.com

Sino Bio takes NMPA priority status for oral drug against IDH1-mutant biliary tract cancer

Sino Biopharmaceutical (HKEX: 01177) has submitted TQB3454, an oral IDH1 inhibitor tablet developed by its subsidiary Chia Tai Tianqing Pharmaceutical Group, for priority review by China’s National Medical Products Administration Center for Drug Evaluation, seeking approval in patients with locally advanced, recurrent, or metastatic biliary tract cancer harboring IDH1 mutations who have progressed on gemcitabine- and fluorouracil-based regimens. The CDE’s inclusion of TQB3454 in its priority review and approval procedures follows a breakthrough therapy designation granted to the asset in April 2023. The filing targets a genomically defined second-line population — patients whose tumors carry IDH1 mutations and who have exhausted both gemcitabine- and fluorouracil-based treatment options, a sequencing requirement that positions TQB3454 in a late-line setting where no approved targeted therapy currently exists in China. The company said it expects to present detailed trial data at a major international academic conference before the end of 2026. No PDUFA-equivalent date has been disclosed. The application is supported by the Phase III TQB3454-III-01 trial (NCT05987358), a randomized, double-blind, placebo-controlled, multicenter study in patients with IDH1-mutant advanced biliary tract cancer. The company announced in March 2026 that a pre-specified interim analysis had met both co-primary endpoints — progression-free survival and overall survival — each crossing protocol-defined superiority thresholds. The company said the safety profile was consistent with known risks and that no new safety signals were identified. Quantitative efficacy data, including hazard ratios and p-values, have not yet been publicly disclosed and are expected to be presented at a forthcoming conference. TQB3454 inhibits the mutant IDH1 enzyme, reducing production of the oncometabolite 2-hydroxyglutarate and thereby alleviating the downstream DNA and histone hypermethylation that drives differentiation blockade in IDH1-mutant tumors. The mechanism is shared with ivosidenib (Tibsovo, Servier), which received US FDA approval in August 2021 for previously treated IDH1-mutant cholangiocarcinoma based on the ClarIDHy Phase III trial — the only globally approved IDH1-directed therapy for biliary tract cancer. Ivosidenib has not been approved by the NMPA, leaving Chinese patients without an authorized targeted option in this molecular subgroup. TQB3454 adds to a competitive landscape that includes biomarker-selected agents across multiple targets, including zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) for HER2-positive biliary tract cancer and zenocutuzumab-zbco (Bizengri, Partner Therapeutics) for NRG1 fusion-positive cholangiocarcinoma, both approved by the US FDA. The company described TQB3454-III-01 as the second successful Phase III study of an IDH1 inhibitor in biliary tract cancer globally, and the first conducted in China. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 3Drug ApprovalPriority ReviewClinical ResultBreakthrough Therapy

100 Deals associated with Zenocutuzumab-zbco

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KEGG	Wiki	ATC	Drug Bank
D11991	-	-	DB15559

R&D Status

Approved

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Indication	Country/Location	Organization	Date
NRG1 gene fusion cholangiocarcinoma	United States	Merus NV	08 May 2026
Adenocarcinoma of pancreas with NRG1 fusion	United States	Merus NV	04 Dec 2024
NRG1 Fusion Positive non-small cell lung cancer	United States	Merus NV	04 Dec 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	United States	Partner Therapeutics, Inc.	17 Nov 2022
ER Positive/HER2 Low Breast Cancer	Phase 2	United States	Merus NV	15 Jan 2018
ER Positive/HER2 Low Breast Cancer	Phase 2	Belgium	Merus NV	15 Jan 2018
ER Positive/HER2 Low Breast Cancer	Phase 2	France	Merus NV	15 Jan 2018
ER Positive/HER2 Low Breast Cancer	Phase 2	Netherlands	Merus NV	15 Jan 2018
ER Positive/HER2 Low Breast Cancer	Phase 2	Portugal	Merus NV	15 Jan 2018
ER Positive/HER2 Low Breast Cancer	Phase 2	Spain	Merus NV	15 Jan 2018
ER Positive/HER2 Low Breast Cancer	Phase 2	United Kingdom	Merus NV	15 Jan 2018
HER2 Positive Cancer	Phase 2	United States	Merus NV	15 Jan 2018
HER2 Positive Cancer	Phase 2	Belgium	Merus NV	15 Jan 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02912949 (eNRGy, ASCO_GI2026)	Phase 2	NRG1 Fusion Positive Pancreatic Cancer \| Bile Duct Neoplasms NRG1+	17	Zenocutuzumab (NRG1+ gastrointestinal tumors)	jfrautzqxs(sooikyuckc) = xzbiqnxgaa avyupnihtp (unooacozwi ) View more	Positive	08 Jan 2026
NCT02912949 (Pubmed \| N Engl J Med) Manual	Phase 2	NRG1 Fusion Positive Solid Tumors	204	Zenocutuzumab 750 mg	folbkopdfe(ozwfwhlxsz) = tzntvvjpzo qanzxhqida (fbwpknuryb, 23 - 37) View more	Positive	06 Feb 2025
				Zenocutuzumab 750 mg (NSCLC)	folbkopdfe(ozwfwhlxsz) = fomgnymase qanzxhqida (fbwpknuryb, 20 - 39)
NCT02912949 (eNRGy, FDA_CDER) Manual	Phase 2	NRG1 Fusion Positive Pancreatic Cancer NRG1 Fusion	30	BIZENGRI	vdkafeqvtm(yqzqdpwxwn) = bbkbyraqne laapbgxjpe (pipzitixbp, 23 - 59) View more	Positive	04 Dec 2024
				BIZENGRI (NRG1 Partner ATP1B1)	vdkafeqvtm(yqzqdpwxwn) = hpjvodywkr laapbgxjpe (pipzitixbp, 23 - 77) View more
NCT02912949 (eNRGy, FDA_CDER) Manual	Phase 2	NRG1 Fusion Positive non-small cell lung cancer NRG1 Fusion	64	BIZENGRI (Previously Treated with Systemic Therapy)	khxnmjzaiv(zteyevxipc) = wqmrwhwnuy vfjkbveljx (abuqaolyur, 22 - 46) View more	Positive	04 Dec 2024
				BIZENGRI (NRG1 Partner CD74)	khxnmjzaiv(zteyevxipc) = apsobyhubf vfjkbveljx (abuqaolyur, 18 - 50) View more
NCT03321981 (CTgov)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Metastatic breast cancer \| HER2 Positive Cancer ... View more	105	Trastuzumab+Zenocutuzumab (Cohort 1 Doublet)	wdrxilofay = iwuqbwfbxd neosuplsrt (vgbzahbqym, szxnbrtllu - pgchogjrig) View more	-	07 Mar 2024
				Trastuzumab+Zenocutuzumab+Vinorelbine (Cohort 1 Triplet)	wdrxilofay = barpxqhpwj neosuplsrt (vgbzahbqym, udslfpimva - ddpvrpebcj) View more
NCT02912949 (ESMO_ASIA2023) Manual	Phase 2	NRG1 Fusion Positive non-small cell lung cancer NRG1 Fusion	85	Zenocutuzumab	irzirjrzty(qzfkqwvqac) = oeuxfdgbbn ckwcrirggb (ckmytwhhas, 23 - 47) View more	Positive	02 Dec 2023
NCT02912949 (eNRGy, ESMO 12023 \| ESMO 22023) Manual	Phase 2	NRG1 Fusion Positive Pancreatic Cancer NRG1 fusion positive	38	Zenocutuzumab	cqsynylgfy(juahbrfdnr) = qvewyrpxpn zcdqrmqfly (pydfahggui, 26 - 65) View more	Positive	23 Oct 2023
NCT02912949 (eNRGy, ASCO2022)	Phase 2	NRG1 Fusion Positive Solid Tumors	99	Zenocutuzumab (MCLA-128)	fwfvuyrpmv(aezsxuknqs) = daprbixqss nfcbqzwujc (sivpgkxihd, 25 - 44) View more	Positive	02 Jun 2022
MCLA-128 (SABCS2022)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast Second line HER2 positive \| HER3	39	Zenocutuzumab 750 mg	fheqighzfj(eemdfsrgcj) = ylkfkverlc nwwqdzwois (vfwjjynwqn, 34 - 63) View more	Positive	15 Feb 2022
				Trastuzumab 8 mg/kg loading, then 6 mg/kg	fheqighzfj(eemdfsrgcj) = bztxoofevk nwwqdzwois (vfwjjynwqn, 38 - 71) View more
NCT03321981 (Corporate Publications) Manual	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive \| HER2 Amplification	39	trastuzumab+vinorelbine+MCLA-128	cywppspniz(aqweqzwezd) = ozivobucdc wmgcridaxd (quccbyoysk, 34 - 63) View more	Positive	10 Dec 2021

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