FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsUrogenital DiseasesImmune System Diseases+ [4]

Active Indication

Locally Advanced Urothelial CarcinomaMetastatic urothelial carcinomaUnresectable Urothelial Carcinoma+ [19]

Inactive Indication

Adenocarcinoma of prostateCastration-Resistant Prostatic CancerEsophageal Carcinoma+ [2]

Originator Organization

Astex Pharmaceuticals, Inc.

Active Organization

Janssen Research & Development LLC

Pivotal SLJanssen-Cilag Ltd.

+ [9]

Inactive Organization

Johnson & Johnson Pharmaceutical Research & Development LLC

License Organization

Janssen Pharmaceuticals, Inc.

Immunomedics, Inc.

Astex Pharmaceuticals, Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (12 Apr 2019),

FGFR positive Transitional Cell Carcinoma

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (South Korea)

Structure/Sequence

Molecular FormulaC25H30N6O2

InChIKeyOLAHOMJCDNXHFI-UHFFFAOYSA-N

CAS Registry1346242-81-6

Clinical Trials associated with Erdafitinib

NCT06919965

/ RecruitingPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Start Date10 Sep 2025

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06319820

/ RecruitingPhase 3

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Start Date18 Apr 2024

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06204614

/ Unknown statusEarly Phase 1IIT

Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors

This research study involves implanting up to 4 microdevices, each small enough to fit inside the tip of a needle, into a tumor. These devices will release microdoses (many thousands of times less than a treatment dose) of different cancer drugs into the tumor. After approximately 72 hours, the devices and small regions of surrounding tissue will be removed and studied. There will be a follow-up visit within 42 days of device removal to assess for potential safety issues or side effects.

Start Date14 Feb 2024

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

100 Clinical Results associated with Erdafitinib

100 Translational Medicine associated with Erdafitinib

100 Patents (Medical) associated with Erdafitinib

438

Literatures (Medical) associated with Erdafitinib

10 Mar 2026·JOURNAL OF CLINICAL ONCOLOGY

Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study

Article

Author: Girvin, Angela ; Thomas, Shibu ; Cicin, Irfan ; Tammaro, Meggan ; Triantos, Spyros ; Siefker-Radtke, Arlene O. ; O'Hagan, Anne ; Moreno, Victor ; Powles, Thomas ; Loriot, Yohann ; Zhu, Wei ; Kang, Taek Won ; Akapame, Sydney

PURPOSE:

First-line treatment options for cisplatin-ineligible patients with metastatic urothelial cancer (mUC) are limited. We conducted a phase II study of erdafitinib, alone or with cetrelimab, in FGFR -altered mUC.

METHODS:

Adults with mUC and select FGFR alterations who are ineligible for cisplatin were randomly assigned 1:1 in a noncomparative design to once-daily erdafitinib 8 mg (with pharmacodynamically guided uptitration to 9 mg) or erdafitinib 8 mg plus intravenous cetrelimab 240 mg once every 2 weeks at cycles 1-4 and 480 mg once every 4 weeks thereafter. Primary end points were investigator-assessed confirmed overall response rate (ORR) and safety; secondary end points included duration of response (DOR), progression-free survival, and overall survival (OS). No statistical hypotheses were tested.

RESULTS:

At data cutoff, 87 patients were randomly assigned and treated (erdafitinib, n = 43; erdafitinib plus cetrelimab, n = 44). Of 64 patients with PD-L1 expression data, 56 (87.5%) had low levels of PD-L1 expression (combined positive score <10). Median survival follow-up was 14.2 months. Investigator-assessed confirmed ORR for erdafitinib was 44.2% (95% CI, 29.1 to 60.1) with one complete response (CR); median DOR and median OS were 9.7 months (95% CI, 4.6 to not estimable [NE]) and 16.2 months (95% CI, 8.3 to NE), respectively. Investigator-assessed confirmed ORR for erdafitinib plus cetrelimab was 54.5% (95% CI, 38.8 to 69.6), with six (13.6%) CRs; median DOR and median OS were 11.1 months (95% CI, 8.8 to NE) and 20.8 months (95% CI, 12.0 to NE), respectively. The most frequent treatment-related adverse events (TRAEs) were hyperphosphatemia (83.7% and 68.2% in erdafitinib and erdafitinib plus cetrelimab groups, respectively), stomatitis (69.8% and 56.8%), and dry mouth (37.2% and 56.8%). Grade ≥3 TRAEs occurred in 46.5% and 45.5% of patients receiving erdafitinib and erdafitinib plus cetrelimab, respectively.

CONCLUSION:

First-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with mUC.

01 Mar 2026·MICROCHIMICA ACTA

Engineering a Gd₂(WO₄)₃–P@rGO heterostructure for enhanced electrochemical sensing and therapeutic drug monitoring of erdafitinib

Article

Author: Mohamed, Rasha M K ; El-Wekil, Mohamed M ; Hassan, Hassan M A ; Alshammari, Khulaif ; Ibrahim, Hossieny ; Alsohaimi, Ibrahim Hotan ; Taha, Rania H

Erdafitinib (ERDF), a pan-FGFR tyrosine kinase inhibitor used in metastatic urothelial carcinoma, demands precise quantification due to its narrow therapeutic index and potential for severe side effects. We report for the first time the fabrication of a Gd₂(WO₄)₃-P@rGO heterostructure as a hybrid electrochemical sensing interface for ERDF detection. The material was synthesized via a facile hydrothermal-ultrasonic approach, producing a structurally integrated composite that leverages the redox activity of Gd₂(WO₄)₃ and the conductivity and defect-rich nature of P-doped rGO. Comprehensive characterization by SEM, TEM, FTIR, XRD, and XPS confirmed the successful formation of a well-dispersed nanocomposite with a crumpled-sheet morphology, uniform Gd₂(WO₄)₃ anchoring, and strong interfacial bonding. The composite electrode demonstrated enhanced electron-transfer kinetics and a significantly amplified ERDF oxidation signal, with a detection limit of 0.0024 nM, high sensitivity (16.670 µA nM⁻¹ cm⁻²), and a wide linear range (0.01-800 nM, R² = 0.9980). Recovery studies in spiked human serum and urine samples yielded excellent results (95.7-104.8% recovery, RSD ≤ 3.65%), validating the sensor's real-world applicability. Importantly, the sensor offers scalable fabrication, requires no toxic reducing agents, and exhibits strong selectivity and long-term stability, making it a novel and sustainable platform for therapeutic drug monitoring, pharmacokinetics, and point-of-care diagnostics.

01 Mar 2026·Clinical Genitourinary Cancer

Preferred Treatment Sequencing for Metastatic Urothelial Carcinoma (mUC) in the Era of Perioperative and First-Line (1L) Checkpoint Inhibitor: Results From a National Survey of Genitourinary Oncologists

Article

Author: Koshkin, Vadim S ; Rosenberg, Jonathan E ; Grivas, Petros ; Plimack, Elizabeth R ; Galsky, Matt D ; Khaki, Ali R ; O'Donnell, Peter H ; Chablani, Priyanka V ; Tawagi, Karine ; Hoffman-Censits, Jeannie ; Gupta, Shilpa

BACKGROUND:

Immune checkpoint inhibitors (ICI) are commonly used in urothelial carcinoma. We sought to understand provider preferences for subsequent treatment of patients after prior ICI.

MATERIALS AND METHODS:

We comprised a group of 11 expert genitourinary medical oncologists in the United States and created a survey regarding treatment sequencing. We present the final responses to this survey, using descriptive statistics.

RESULTS:

We received 78 responses (34%) from 227 genitourinary oncologists between May and August 2024; most were practicing for >5 years (62%) and were seeing >25 patients with metastatic urothelial carcinoma (mUC) yearly (72%). For patients with progression while receiving adjuvant ICI, 51% of respondents were somewhat/very likely to use enfortumab vedotin/pembrolizumab (EVP) as next therapy line. For patients with progression after prior ICI, 1/3 of respondents would consider first-line (1L) EVP irrespective of the interval from prior ICI completion. For ICI given in nonmuscle invasive bladder cancer and muscle-invasive bladder cancer, 43% and 45%, respectively would consider EVP > 6 months post-ICI completion. After progression on EVP, 77% were somewhat/very likely to give platinum-based chemotherapy, and most would not include combination or switch maintenance ICI. Similarly, 80% were somewhat/very likely to recommend non-ICI clinical trials in the second-line setting after EVP, and 87% were somewhat/very likely to offer erdafitinib for susceptible FGFR3 alterations.

CONCLUSION:

Survey-based opinions can effectively capture treatment selection preferences for mUC and could inform future clinical trial design. Additional data, including the impact of residual toxicity from 1L EVP, are needed to better understand real-world treatment sequencing patterns.

News (Medical) associated with Erdafitinib

23 Mar 2026

·www.prnewswire.com

Craig Tendler, M.D., JNJ's Former Global Head of Oncology Clinical Development, to Lead TuHURA Bioscience's VISTA Program in AML and other Blood Related Cancers

Distinguished physician with a career spanning over 29 years in drug development and medical affairs highlighted by blockbuster successes in hematology and oncology Coordinated and achieved more than 30 Oncology regulatory approvals and 15 new medical entity approvals, including four biologic or cell therapy approvals for various stages of multiple myeloma currently generating more than $16 billion in worldwide sales TAMPA, Fla., March 23, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced Dr. Craig L. Tendler will provide strategic, operational and other related services consistent with those of a Chief Medical Officer (CMO). He will also continue with his current role as member of the Board of Directors. Dr. Tendler will work with the Company to oversee clinical development strategy and operations of the company's pipeline, including its VISTA inhibiting antibody, TBS-2025. "Craig has been an active and valued member of our Board and enthusiastically agreed to provide strategic, operational and other related services consistent with those of a CMO. His decades of clinical and regulatory experience in accelerating drug development across therapeutic areas, notably in hematologic malignancies, will be of particular value to our TBS-2025 program," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "I am confident that his recent leadership role and strategic contributions to JNJ's menin inhibitor, bleximenib in NPM1 mutated AML, will prove invaluable to our regulatory pathway and development of TBS-2025 in AML and other blood related cancers. I look forward to working with Craig as we unlock the value in VISTA and other clinical programs." Dr. Craig Tendler, added, "I am excited about the potential benefits of TBS-2025 for blood- related cancers where the negative checkpoint, VISTA, has been implicated in playing a critical immunosuppressive role in both therapy failure and poor overall survival in AML, particularly in the molecularly defined subset of NPM1 mutated AML. We have already received preliminary feedback from the Division of Hematologic Malignancies I of the FDA on the early development plan and will continue to work closely with the Agency to accelerate the clinical development of TBS-2025, both as monotherapy and in combination with menin inhibitors, an area where I have substantial experience." Dr. Tendler, a distinguished thirty-year industry veteran, will provide strategic and operational services consistent with those of a CMO while continuing his role as a member on the TuHURA Board of Directors. Dr. Tendler is a seasoned professional, previously serving as the Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development. During his tenure at JNJ, Dr. Tendler and his team worked in collaboration with the FDA and the European Medicines Agency to secure the worldwide approvals of transformational treatments in prostate cancer (ZYTIGA®, AKEEGA®, and ERLEDA®), hematologic malignancies (DARZALEX®, CARVYKTI®, TECVAYLI®, TALVEY®, IMBRUVICA®) as well as for lung (RYBREVANT®) and bladder cancer (BALVERSA®). He has been a leader and key participant in four Oncology Drug Advisory Committee (ODAC) presentations, achieved 13 FDA breakthrough designations, and led clinical diligence teams for numerous oncology business development opportunities culminating in Janssen's acquisitions of Cougar Biotechnology, Aragon Pharmaceuticals, and TARIS Biomedical along with Janssen's co-development agreements with Legend Biotech, Pharmacyclics/AbbVie, Tesaro/GSK, Yuhan Corporation, and GenMab A/S. Prior to joining Johnson & Johnson Innovative Medicine, Dr. Tendler served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, he has served as Co-Chair of the Friends of Cancer Research Corporate Council, member of the Bloomberg New Economy International Cancer Coalition, and member of the Admissions Committee, Mount Sinai School of Medicine. He was an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and an NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland. Dr. Tendler earned his undergraduate degree from Cornell University and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in its acquisition by merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb moving into Phase 2 development in mutNPM1 r/r AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit and connect with TuHURA on Facebook, X, and LinkedIn. Cautionary Statement Regarding Forward-Looking Statements This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-Looking Statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on TuHURA's website and at . The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Investor Contact: Monique Kosse Gilmartin Group [email protected] SOURCE TuHURA Biosciences, Inc. 21% more press release views with Request a Demo

ImmunotherapyPhase 3Executive ChangePhase 2Breakthrough Therapy

16 Mar 2026

·www.prnewswire.com

Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer

Data presented at EAU 2026 show an 89 percent complete response rate in intermediate-risk disease with durable responses observed over 18 months and tolerable safety profile Erda-iDRS has the potential to be the first targeted treatment for early–stage bladder cancer March 13, 2026 -- Johnson & Johnson (NYSE:JNJ) today announced results from an open-label, multicenter Phase 1 study evaluating an investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS) in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC) whose tumors harbor select fibroblast growth factor receptor (FGFR) alterations. The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease. These findings support continued development of this targeted approach with ongoing Phase 2 and Phase 3 studies evaluating Erda-iDRS across risk settings. Data were presented during a late-breaking oral session at the European Association of Urology (EAU) 2026 Annual Meeting (Abstract #LB26-0083).1 FGFR alterations are common in early-stage bladder cancer, occurring in approximately 70 percent of intermediate-risk and 40 percent of high-risk non–muscle-invasive bladder cancer tumors.2,3 Because these changes may drive tumor growth, they represent an important therapeutic target in this setting. Erda-iDRS is designed to provide prolonged release of erdafitinib, an oral kinase inhibitor, directly into the bladder via intravesical administration over a three-month period, and may enable localized treatment while aiming to minimize systemic exposure and the risk of adverse events associated with oral administration. "Intermediate-risk non–muscle-invasive bladder cancer is defined by recurrences, and many patients undergo repeated procedures as their tumors return," said Antoni Vilaseca Cabo,* M.D., adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, and presenting author. "In this study, treatment with Erda-iDRS led most patients with FGFR-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time. Achieving and maintaining a complete response is particularly meaningful in this setting, where recurrence is common and requires repeated surgical intervention." "For patients with FGFR-altered non–muscle-invasive bladder cancer, care has historically not been guided by precision-based approaches," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson. "The high and durable complete responses demonstrated with Erda-iDRS highlight the opportunity to deliver a targeted therapy to these patients. Bringing a biology-based approach into earlier stages of this disease has the potential to change how these patients are treated." In this Phase 1 study, Erda-iDRS was evaluated in patients with non–muscle-invasive bladder cancer harboring select FGFR alterations identified by urine and/or tissue testing. As of November 3, 2025, 62 patients with recurrent intermediate-risk non–muscle-invasive bladder cancer and 26 patients with recurrent, Bacillus Calmette-Guérin (BCG)-experienced, high-risk non–muscle-invasive bladder cancer had received treatment. The primary endpoint was safety, with the secondary endpoints assessing complete response rate and duration of CR in the intermediate-risk cohort and recurrence-free survival in the high-risk cohort.1 In the intermediate-risk cohort, Erda-iDRS was evaluated as a non-surgical treatment for visible tumors. The complete response rate was 89 percent (95 percent confidence interval [CI], 78-95), based on tumor assessments during the initial treatment period. Among responders, the median duration of complete response was 18 months (95 percent CI, 14-25), with a median follow-up of 18 months (range, 15-21), indicating prolonged responses over time. Forty-nine percent of patients remain in follow-up.1 In the high-risk cohort, patients treated with Erda-iDRS had a median recurrence-free survival of 20 months (95 percent CI, 15-30), with a 12-month recurrence-free survival rate of 83 percent (95 percent CI, 62-93). With a median recurrence-free survival follow-up of 24 months (range, 15-30), 31 percent of patients remain in follow-up.1 Treatment was generally well tolerated, as evidenced by the absence of dose-limiting toxicities and a safety profile characterized by predominantly local adverse events. In the combined cohorts, the most frequent treatment-related adverse events (TRAEs) were hematuria (32 percent) and dysuria (22 percent). Grade 3 or higher TRAEs occurred in four patients (5 percent). Eight patients (9 percent) discontinued treatment due to adverse events, and two patients (2 percent) experienced serious TRAEs. Pharmacokinetic analyses demonstrated prolonged drug levels in the urine, with limited systemic exposure and no observed hyperphosphatemia.1 Phase 2 and Phase 3 studies are ongoing to evaluate Erda-iDRS in intermediate- and high-risk non–muscle-invasive bladder cancer. The MoonRISe program includes the Phase 3 MoonRISe-1 study (NCT06319820) in intermediate-risk disease in the adjuvant setting (after tumor resection), the Phase 2 MoonRISe-2 study (NCT05316155) in intermediate-risk disease in the ablative setting (evaluating treatment of visible tumors without surgery), and the Phase 3 MoonRISe-3 study (NCT06919965) in patients with high-risk papillary non–muscle-invasive bladder cancer who received prior BCG therapy, including those with BCG-unresponsive disease, in the adjuvant setting.4,5,6 Erda-iDRS is an investigational intravesical drug delivery system designed to deliver prolonged, localized erdafitinib, an oral kinase inhibitor, directly to the bladder. The safety and efficacy of Erda-iDRS are being evaluated in a Phase 1 study in patients with non–muscle-invasive bladder cancer (NMIBC), including those with high-risk, BCG-unresponsive disease and intermediate-risk disease with visible tumors. Additional Phase 2 and Phase 3 studies are ongoing to further assess Erda-iDRS across intermediate- and high-risk NMIBC. In 2008, Janssen Pharmaceuticals entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib. Non–muscle-invasive bladder cancer (NMIBC) is an early stage of bladder cancer confined to the lining of the bladder. It accounts for approximately 75 percent of newly diagnosed bladder cancer cases. NMIBC is categorized as low-, intermediate-, or high-risk based on tumor characteristics and likelihood of recurrence or progression.7 Patients with intermediate-risk NMIBC experience frequent tumor recurrences that often require repeated procedures and ongoing monitoring. High-risk NMIBC carries a greater likelihood of progression to muscle-invasive disease, which may require radical cystectomy.8,9,10 Despite available treatments, recurrence and progression remain common across intermediate- and high-risk disease, underscoring the need for durable bladder treatment options. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. 1 Vilaseca A, et al. Safety and efficacy of the erdafitinib (erda) intravesical delivery system, TAR-210, in patients with non–muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) harboring select FGFR mutations or fusions: phase 1 first-in-human study. Presented at: 2026 European Association of Urology (EAU); March 13, 2026; London. 2 Roupret M, et al. Eur Urol. 2022;87(S 1):A0673 3 Catto JWF, et al. Ann Oncol. 2024;35:98-106 4 ClinicalTrials.gov. A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1). https://clinicaltrials.gov/study/NCT06319820. Accessed March 2026. 5 ClinicalTrials.gov. Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer. https://clinicaltrials.gov/study/NCT05316155. Accessed March 2026. 6 ClinicalTrials.gov. A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (MoonRISe-3). https://clinicaltrials.gov/study/NCT06919965. Accessed March 2026. 7 Johnson & Johnson. Bladder cancer. Johnson & Johnson Innovative Medicine. Published June 30, 2025. https://www.jnj.com/innovativemedicine/oncology/bladder-cancer. Accessed March 2026. 8 Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010 9 Brooks NA, O'Donnell MA. Treatment options in non–muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475 10 Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939-949. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultLicense out/in

01 Mar 2026

·www.bccrc.ca

Blood test expands access to FGFR-targeted therapy for metastatic urothelial cancer

Researchers at BC Cancer Research Institute, led by Dr. Bernie Eigl, director of the Provincial Clinical Trials Office, and Dr. Alex Wyatt, senior scientist and scientific director of the Cancer Genetics and Genomics Laboratory, examined whether a blood test that analyzes cancer-derived DNA found in the blood, called circulating tumour DNA (ctDNA), could help identify more patients with metastatic urothelial carcinoma – an aggressive form of bladder cancer – who are eligible for FGFR-targeted therapy. FGFR-targeted therapy is a precision cancer treatment that targets the cellular pathways that enable the growth of cancer cells. The study, published in Nature Communications, compares the blood-based ctDNA test with standard tumour tissue testing to detect FGFR alterations that determine eligibility for treatments such as erdafitinib. The paper shows that ctDNA testing performs strongly alongside tissue testing and may help identify additional patients who could benefit from FGFR-targeted therapies. This project represents a strong pan-Canadian collaboration, involving researchers from 12 hospitals across multiple provinces. One of the study’s co-first authors, PhD student Andrew Murtha, is supported by a BC Cancer Rising Star Award through the BC Cancer Foundation, which also helped fund this research study. Urothelial cancer is difficult to treat, and identifying FGFR alterations reliably is important for guiding targeted therapy. However, tumour tissue testing has limitations – a biopsy may not capture all the genetic changes across the tumour, and some samples don’t contain enough usable material for testing. Additionally, technical details of testing methods can vary between hospitals. “The current clinical standard-of-care is to test cancer tissue obtained near the time of first cancer diagnosis – but cancer can change over time and suitable tissue may not be available,” says Dr. Wyatt. “Testing a recent ctDNA sample gives us a chance to pick up actionable changes that were not detected in the original cancer tissue.” In this prospective, multi-centre study, the team evaluated 208 patients undergoing routine FGFR tissue testing. They found that the blood-based ctDNA testing matched tissue results 90% of the time and detected FGFR alterations in 26% of patients, equaling the frequency observed in tissue. Notably, the ctDNA test identified seven additional patients with FGFR alterations that tissue testing missed, likely reflecting tumour heterogeneity or tissue limitations. Serial blood collections also showed that ctDNA can provide ongoing insight into tumour changes in a practical and minimally invasive way. “Identifying FGFR alterations via ctDNA when tissue testing failed to demonstrate an alteration means we can provide active therapies that patients could otherwise not access,” explains Dr. Eigl. “In FGFR-positive patients, these treatments have a meaningful impact on survival.” Among the 21 patients who received erdafitinib after testing, the median progression-free survival was 7.5 months. One patient whose FGFR alteration was detected only through the blood-based ctDNA test remained on treatment for 33 months, highlighting the potential clinical value of ctDNA testing to identify patients who may benefit from targeted therapy. These findings suggest that integrating ctDNA with tissue-based approaches may expand access to FGFR-targeted therapies and provide a more complete genomic picture of patients with metastatic urothelial cancer. The team is now working to expand access to routine clinical ctDNA testing through the Cancer Genetics and Genomics Laboratory. The next step is to make a clinical-grade version of their home-grown ctDNA test available to all patients with metastatic urothelial cancer in BC.

Clinical ResultClinical Study

100 Deals associated with Erdafitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10927	Erdafitinib	L01XE	DB12147

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Locally Advanced Urothelial Carcinoma	China	Janssen-Cilag International NV	08 Jan 2025
Metastatic urothelial carcinoma	European Union	Janssen-Cilag International NV	22 Aug 2024
Metastatic urothelial carcinoma	Iceland	Janssen-Cilag International NV	22 Aug 2024
Metastatic urothelial carcinoma	Liechtenstein	Janssen-Cilag International NV	22 Aug 2024
Metastatic urothelial carcinoma	Norway	Janssen-Cilag International NV	22 Aug 2024
Unresectable Urothelial Carcinoma	European Union	Janssen-Cilag International NV	22 Aug 2024
Unresectable Urothelial Carcinoma	Iceland	Janssen-Cilag International NV	22 Aug 2024
Unresectable Urothelial Carcinoma	Liechtenstein	Janssen-Cilag International NV	22 Aug 2024
Unresectable Urothelial Carcinoma	Norway	Janssen-Cilag International NV	22 Aug 2024
FGFR2 positive Transitional Cell Carcinoma	South Korea	Janssen Korea Ltd.	24 Nov 2022
FGFR3 positive Transitional Cell Carcinoma	South Korea	Janssen Korea Ltd.	24 Nov 2022
Bladder Cancer	Canada	Janssen Biotech, Inc.	09 Dec 2019
Transitional Cell Carcinoma	Canada	Janssen, Inc.	25 Oct 2019
FGFR positive Transitional Cell Carcinoma	United States	Janssen Biotech, Inc.	12 Apr 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Urothelial Carcinoma	NDA/BLA	China	Janssen Cilag SpA	15 Dec 2023
Advanced Urothelial Carcinoma	NDA/BLA	China	Janssen Biotech, Inc.	15 Dec 2023
Advanced Urothelial Carcinoma	NDA/BLA	China	Shanghai Johnson & Johnson Pharmaceutical Ltd.	15 Dec 2023
FGFR positive Non-Muscle Invasive Bladder Neoplasms	Phase 3	United States	Janssen Research & Development LLC	10 Sep 2025
FGFR positive Non-Muscle Invasive Bladder Neoplasms	Phase 3	Japan	Janssen Research & Development LLC	10 Sep 2025
FGFR positive Non-Muscle Invasive Bladder Neoplasms	Phase 3	Argentina	Janssen Research & Development LLC	10 Sep 2025
FGFR positive Non-Muscle Invasive Bladder Neoplasms	Phase 3	Belgium	Janssen Research & Development LLC	10 Sep 2025
FGFR positive Non-Muscle Invasive Bladder Neoplasms	Phase 3	Brazil	Janssen Research & Development LLC	10 Sep 2025
FGFR positive Non-Muscle Invasive Bladder Neoplasms	Phase 3	France	Janssen Research & Development LLC	10 Sep 2025
FGFR positive Non-Muscle Invasive Bladder Neoplasms	Phase 3	Germany	Janssen Research & Development LLC	10 Sep 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03473743 (NORSE, Pubmed \| J Clin Oncol)	Phase 2	Metastatic urothelial carcinoma First line FGFR Alterations	87	Erdafitinib 8 mg	xxtsrvwnju(ewzsidiemn) = fkvgfgtcma dzcdtbkmoo (efvjmqmaur ) View more	Positive	10 Mar 2026
				Erdafitinib 8 mg plus cetrelimab	xxtsrvwnju(ewzsidiemn) = nnfaguclfl dzcdtbkmoo (efvjmqmaur ) View more
ESMO_SRC2026	Not Applicable	Central Nervous System Neoplasms	9	infigratinib	pbzlidwmvv(clrflvaccl) = Toxicities included fatigue, visual changes, hyperphosphatemia and stomatitis. Two patients required dose reductions and four required discontinuation due to toxicity (visual changes - 1, hyperphosphatemia - 1 and fatigue - 2) toghzueiqf (cchpmytoya )	Positive	09 Mar 2026
ASCO_GU2026	Not Applicable	Advanced Urothelial Carcinoma	180	Erdafitinib (received erda followed by EV)	iwazyzevyf(yxfcbofxox) = oqtgmcbbrw bfxefjqkgn (mwwsdqrydl, 14 - 21) View more	Positive	26 Feb 2026
				Erdafitinib (EV followed by erda)	iwazyzevyf(yxfcbofxox) = gcwnovalfu bfxefjqkgn (mwwsdqrydl, 4.9 - 9.7) View more
NCT04172675 ( THOR-2 \| THOR-2, CTgov)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	107	Erdafitinib	pwmlrcxpmd(ylrnnmepoe) = zfxdsqplyi rhkegywgon (lkohucmgvj, hhovexdnkj - nntbkpxxov) View more	-	01 Aug 2025
NCT03390504 (THOR \| THOR study (Cohort 2) \| THOR study \| THOR \| Study BLC3001, CTgov)	Phase 3	Advanced Urothelial Carcinoma \| Urothelial Carcinoma of the Urinary Bladder \| Transitional Cell Carcinoma	629	Erdafitinib (Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg)	simqhzxwrj(jpuwjfavzu) = fztalsokam rmxoaahwjb (qiivyacxcd, mmpcqbogwk - hbcrwnsgpk) View more	-	14 May 2025
				Vinflunine+Docetaxel (Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2))	simqhzxwrj(jpuwjfavzu) = cceucbxnsj rmxoaahwjb (qiivyacxcd, ujtpxcmdpo - yfdqngdpuh) View more
NCT04083976 (RAGNAR, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	316	erdafitinib (Broad Panel Cohort)	bdcuhzmoux = valbxzylfw pamztzftxx (xjzdojfpzz, qujgurpexw - ydrgxndjsb) View more	-	24 Feb 2025
				erdafitinib (Pediatric Cohort)	bdcuhzmoux = muyomzhzvw pamztzftxx (xjzdojfpzz, ivizkxrxkw - varstjxgcf) View more
NCT04963153 (ETCTN 10483, ASCO_GU2025) Manual	Phase 1	Metastatic urothelial carcinoma FGFR3 Mutation \| FGFR2 Mutation	9	Erdafitinib + Enfortumab Vedotin	qeemfauesg(gwvlxwczwv) = hyperphosphatemia (88%), mucositis (88%), high AST (88%), hypercalcemia (75%), palmar plantar erythrodysesthesia (75%), peripheral neuropathy (75%), alopecia (63%), diarrhea (63%), hypoalbuminemia (63%) and hypomagnesemia (63%). ktidimxdil (nenzggmcev ) View more	Positive	13 Feb 2025
ASN2024	Not Applicable	Bile Duct Neoplasms \| Transitional Cell Carcinoma FGFR2-rearranged	16	Erdafitinib	lnkoichxav(tcteqklcmd) = fmwstqppcg tecsdfyyde (bjrcixxrek ) View more	Negative	25 Oct 2024
				Futibatinib	klohmacbcv(lmrdfwonwi) = etyhojtspl dyuvvizdce (oerujtyosb )
NCT03210714 (APEC1621B, CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Refractory Central Nervous System Lymphoma \| Recurrent Medulloblastoma ... View more	20	Computed Tomography+Erdafitinib	fvjmtrenwq = bildgbjdig nmybsyftqq (pcalzprkgb, rbhailytwr - uitdolyygc) View more	-	19 Sep 2024
NCT05316155 (ESMO2024)	Phase 1/2	FGFR positive Cholangiocarcinoma	-	TAR-210	idjdlvocxr(zaywgwauro) = qpirqgjklg ujatkuxzdd (xfgzhqkzta ) View more	-	15 Sep 2024

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