ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), TrkA antagonists(Nerve growth factor receptor Trk-A antagonists)

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases+ [8]

Active Indication

Non-Small Cell Lung CancerReactive oxygen species 1 positive non-small cell lung cancerNTRK fusion-positive solid tumors+ [27]

Inactive Indication

Advanced breast cancerAdvanced Prostate CarcinomaAdvanced Sarcoma+ [10]

Originator Organization

Nerviano Medical Sciences S.r.l

Active Organization

F. Hoffmann-La Roche Ltd.Hoffmann-La Roche, Inc.

Roche China Holding Ltd.

+ [6]

Inactive Organization-

License Organization

Nerviano Medical Sciences S.r.l

Ignyta, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (18 Jun 2019),

NTRK fusion-positive solid tumors

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea)

Structure/Sequence

Molecular FormulaC31H34F2N6O2

InChIKeyHAYYBYPASCDWEQ-UHFFFAOYSA-N

CAS Registry1108743-60-7

Clinical Trials associated with Entrectinib

NCT06528691

/ RecruitingPhase 2IIT

PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors (GLOBOTRK)

This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

Start Date01 May 2026

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

[+1]

CTR20253435

/ CompletedNot Applicable

评估受试制剂恩曲替尼胶囊与参比制剂恩曲替尼胶囊（罗圣全®）作用于健康成年受试者的餐后生物等效性研究

[Translation] A postprandial bioequivalence study evaluating the test formulation entrectinib capsules and the reference formulation entrectinib capsules (Luoshengquan®) in healthy adult subjects

主要研究目的研究餐后状态下单次口服受试制剂恩曲替尼胶囊与参比制剂恩曲替尼胶囊（罗圣全®）在健康成年受试者体内的药代动力学，评价餐后状态下口服两种制剂的生物等效性。次要研究目的研究受试制剂恩曲替尼胶囊和参比制剂“罗圣全®”在健康受试者中的安全性。

[Translation]

Primary Study Objectives To investigate the pharmacokinetics of the test formulation, entrectinib capsules, and the reference formulation, entrectinib capsules (Luoshengquan®), in healthy adult volunteers after a single oral dose in the fed state, and to evaluate the bioequivalence of the two formulations after oral administration in the fed state. Secondary Study Objectives To investigate the safety of the test formulation, entrectinib capsules, and the reference formulation, Luoshengquan®, in healthy volunteers.

Start Date15 Sep 2025

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

CTR20253434

/ CompletedNot Applicable

评估受试制剂恩曲替尼胶囊与参比制剂恩曲替尼胶囊（罗圣全®）作用于健康成年受试者的空腹生物等效性研究

[Translation] A fasting bioequivalence study evaluating the test product entrectinib capsules and the reference product entrectinib capsules (Luoshengquan®) in healthy adult subjects

主要研究目的研究空腹状态下单次口服受试制剂恩曲替尼胶囊与参比制剂恩曲替尼胶囊（罗圣全®）在健康成年受试者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性。次要研究目的研究受试制剂恩曲替尼胶囊和参比制剂“罗圣全®”在健康受试者中的安全性。

[Translation]

Primary Study Objectives To investigate the pharmacokinetics of the test formulation, entrectinib capsules, and the reference formulation, entrectinib capsules (Luoshengquan®), in healthy adult volunteers after a single oral dose under fasting conditions, and to evaluate the oral bioequivalence of the two formulations under fasting conditions. Secondary Study Objectives To investigate the safety of the test formulation, entrectinib capsules, and the reference formulation, Luoshengquan®, in healthy volunteers.

Start Date12 Sep 2025

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

100 Clinical Results associated with Entrectinib

100 Translational Medicine associated with Entrectinib

100 Patents (Medical) associated with Entrectinib

629

Literatures (Medical) associated with Entrectinib

01 Oct 2026·GENE

A systematic evaluation of the efficacy and safety of entrectinib in anaplastic thyroid carcinoma

Article

Author: Shen, Xiawei ; Jie, Ran

Anaplastic thyroid carcinoma (ATC) is a highly aggressive malignancy with limited treatment options and poor responsiveness to conventional chemotherapy. In this study, we found that TrkA expression was markedly elevated in clinical ATC tissues compared with adjacent normal thyroid tissue. Knockdown of NTRK1, which encodes TrkA, reduced cell viability and sensitized ATC cells to paclitaxel. Consistently, the Trk inhibitor entrectinib decreased viability of genetically diverse ATC cell lines with nanomolar IC₅₀ values, and demonstrated synergy with paclitaxel across all tested lines. In vivo, entrectinib significantly delayed tumour progression in two independent xenograft studies, while combination therapy produced the most sustained suppression of tumour growth and the greatest extension of survival. Entrectinib was well tolerated at the administered dose, with no significant changes in body weight and serum biochemical markers. Collectively, these findings identify TrkA as a potential therapeutic target in ATC and support further investigation of entrectinib-based combination strategies to improve ATC treatment outcomes.

01 May 2026·JCO Precision Oncology

Switching Tracks: Activity of Entrectinib After Progression While on Larotrectinib in Neurotrophin Receptor Tyrosine Kinase–Fused Pediatric High-Grade CNS Tumors

Article

Author: Pfister, Stefan M. ; Harting, Inga ; Zinke, Claudia ; Fankhauser, Laura ; Milde, Till ; Hardin, Emily C. ; Witt, Olaf ; Pajtler, Kristian W. ; Selt, Florian ; Bartels, Ute K. ; van Tilburg, Cornelis M. ; Stark, Sebastian

01 May 2026·Neuro-oncology advances

TRK inhibitors in pediatric gliomas

Review

Author: Perreault, Sébastien ; Doz, François

Abstract:

The NTRK1, NTRK2, and NTRK3 genes encode the TRKA, TRKB, and TRKC receptors, critical for nervous system development. Gene fusions involving neurotrophic tyrosine receptor kinase (NTRK) are found in various cancers. In the pediatric population, NTRK gene fusions have been identified in up to 5.3% of high-grade gliomas (HGGs) and 2.5% of low-grade gliomas (LGGs). The prevalence is notably higher in young children, particularly in infantile hemispheric gliomas, where the fusion frequency is about 20%.Targeted therapies with TRK inhibitors (TRKi), including larotrectinib and entrectinib, have shown promising efficacy with rapid and durable responses for patients with LGGs and HGGs.TRKi are usually well tolerated, but on-target and off-target adverse events have been reported, such as increased AST/ALT, fatigue, decreased neutrophil, weight gain, and fractures with entrectinib.Resistance to TRKi arises from on-target mutations or new pathway activations, with second-generation inhibitors addressing some resistant cases.Despite efficacy, challenges remain in diagnosis, treatment access, and long-term safety, particularly regarding cognitive development and bone health.Overall, TRKi represent a significant advance for treating NTRK fusion-positive CNS tumors, especially in pediatric populations, offering new hope for patients with limited treatment options. Further studies are required to optimize their use and address unresolved challenges.

News (Medical) associated with Entrectinib

09 Jun 2026

·www.fiercebiotech.com

GSK inks $10.6B Nuvalent buyout to challenge Roche and Pfizer in lung cancer

GSK CEO Luke Miels said the deal “will strengthen our operating profit ... through the dolutegravir loss of exclusivity period.”\n GSK has struck a deal to buy Nuvalent for $10.6 billion, securing two near-approval cancer therapies that could challenge products from Roche, Pfizer and other drugmakers. The FDA is set to rule on whether to approve Nuvalent’s ROS1 inhibitor zidesamtinib in September and reach a decision on the biotech’s ALK inhibitor neladalkib in November. With two near-approval assets, plus a phase 1 HER2 inhibitor and preclinical programs, the deal offers near-term growth drivers to ease the pressure GSK could face as generics erode sales of a key HIV drug from 2028 to 2030.“Subject to FDA approvals, the acquisition will deliver revenue growth from 2027. This is what our investors have been asking,” GSK CEO Luke Miels said on a call with the media early Tuesday morning. “It will strengthen our operating profit for GSK through the dolutegravir loss of exclusivity period.”Nuvalent filed for FDA approval of zidesamtinib in ROS1-positive non-small cell lung cancer (NSCLC) patients who have previously received a tyrosine kinase inhibitor (TKI). Before accepting GSK’s offer, the biotech said (PDF) it planned to apply to expand the label in the second half of the year to include patients without prior TKI exposure.Zidesamtinib could pose a threat to Pfizer’s TKI inhibitor Xalkori, which Nuvalent named as the first-line standard of care. Treatment guidelines also recommend (PDF) Roche’s Rozlytrek, Bristol Myers Squibb’s Augtyro and Nuvation Bio’s Ibtrozi, especially against brain metastases. Nuvalent has identified improved durability and reduced central nervous system side effects as ways to differentiate zidesamtinib.The FDA is reviewing neladalkib in TKI-pretreated, ALK-positive NSCLC. Nuvalent is enrolling patients in a phase 3 trial that is pitting the ALK inhibitor against Roche’s Alecensa in TKI-naive patients. Alecensa is the first-line standard of care and Pfizer’s Lorbrena is the preferred second-line treatment, according to Nuvalent. Miels named a recent seven-year analysis of Pfizer’s phase 3 Crown study as a driver of GSK\'s interest in neladalkib. The data showed Pfizer’s Lorbrena “has very good efficacy but a very, very difficult side effect profile to manage,” Miels said. Because patients are often relatively young, the downsides to a drug that impacts their ability to care for their kids and lead active lives are particularly severe, Miels said.The duration of treatment factored into GSK’s valuation of Nuvalent. The target mutations are found in a small subset of patients—about 3% to 5% of people with NSCLC are ALK-positive—but patients who are eligible for treatment spend longer on the drugs than is typical for many cancers. That means there are “very long tails to these products,” Miels said. About 1% to 3% of patients have ROS1 mutations. GSK sees “multiblockbuster potential” for zidesamtinib and neladalkib, leading it to agree to pay $124 a share to buy the biotech. Nuvalent’s stock closed at $88.49 on Monday. The outlay is well beyond the $2 billion to $4 billion deal range that Miels targeted after becoming CEO early this year. Yet the GSK leader maintained that the Nuvalent buyout is in line with the types of deals the company has been pursuing and striking. The difference is that instead of paying up to $4 billion for a biotech with one attractive asset, GSK is paying $10.6 billion for a company with multiple molecules of interest. “If you take apart the components, it\'s consistent with our approach so far,” Miels said. If zidesamtinib or neladalkib wins FDA approval, the deal will accelerate GSK’s entry into lung cancer and provide a potential launchpad for its B7-H3 antibody-drug conjugate (ADC) risvutatug rezetecan. GSK started a phase 3 trial of the ADC in small cell lung cancer last year.

Phase 3AcquisitionPhase 1Drug ApprovalADC

02 Jun 2026

·www.biospace.com

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne ® Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company 1 BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc ., a global, patient-focused precision medicine company , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne ® CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance ® ) and fulvestrant. Itovebi is a therapy developed by Genentech, a member of the Roche group, which is approved for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. This decision from the FDA follows the approval of FoundationOne ® Liquid CDx, Foundation Medicine’s blood-based comprehensive genomic profiling (CGP) test, for the same therapy combination and indication in October 2024. Of all breast cancer cases, approximately 70% are HR-positive, HER2-negative. 2 Within this patient population, PIK3CA is mutated in approximately 40% of patients. 3 An analysis of the agreement of identified PIK3CA mutation status between the FoundationOne CDx and FoundationOne Liquid CDx tests for patients in the INAV0120 trial demonstrated high concordance between the two assays. “The prevalence of PIK3CA mutations found in HR-positive, HER2-negative breast cancer makes it extremely important to have high quality, FDA-approved tests to match patients to the most effective therapy options in a timely manner,” said Todd Druley, M.D., Ph.D., chief medical officer at Foundation Medicine. “While actionable genomic alterations like PIK3CA may be identified by blood-based biopsy, some patients’ tumors may not be shedding adequate levels of tumor DNA into the blood for these alterations to be detected. In these cases, confirmatory tissue testing may help match more breast cancer patients to this therapy.” Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. With this most recent approval, Foundation Medicine has eight FDA-approved companion diagnostic indications for breast cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company. 1,4 “When someone is diagnosed with metastatic breast cancer or experiences a recurrence of their disease, making decisions about treatment can feel extremely overwhelming,” said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. “Having two high quality FDA-approved biomarker tests to detect PIK3CA mutations using different sample types opens more doors to help match patients to this targeted treatment regimen in the first line setting.” About Foundation Medicine Foundation Medicine is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. We provide tests and solutions to transform care throughout a patient’s experience, from defining a diagnosis to determining the appropriate treatment to ongoing monitoring. We help accelerate the development of new personalized therapies by leveraging our vast knowledge of precision medicine, real world data and AI-powered tools, expanding the information our diagnostic solutions provide to enable improved outcomes for patients. Every day, we are inspired to think differently to transform the lives of people living with cancer and other diseases. For more information, visit us at and follow us on LinkedIn , X , YouTube , Facebook and Instagram . About FoundationOne ® CDx FoundationOne ® CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy which may pose a risk. For the complete label, including companion diagnostic indications and important risk information, please visit . About FoundationOne ® Liquid CDx FoundationOne ® Liquid CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes, rearrangements in 8 genes and copy number alterations in 3 genes, and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for ROZLYTREK ® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO ® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit . Foundation Medicine ® and FoundationOne ® are registered trademarks of Foundation Medicine, Inc. 1 Data on File, Foundation Medicine, Inc., 2025 2 Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst . 2014;106(5). 3 Bhave, M.A., Quintanilha, J.C.F., Tukachinsky, H. et al. Comprehensive genomic profiling of ESR1 , PIK3CA , AKT1 , and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice. Breast Cancer Res Treat . 2024;207:599–609. 4 Data on File, Foundation Medicine, Inc., 2026 Contacts Holly Campbell, 480-213-8368 newsroom@foundationmedicine.com

Drug ApprovalClinical Study

01 Jun 2026

·www.biospace.com

US FDA Approves FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for TALZENNA® (talazoparib) in Combination with XTANDI® (enzalutamide) to Identify Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

With these approvals, Foundation Medicine now has nine companion diagnostic indications for prostate cancer, the most of any company 1 BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc. , a global, patient-focused precision medicine company, today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for Pfizer’s TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with both BRCA mutated and non-BRCA HRR gene-mutated mCRPC. Prostate cancer is the second most common cancer in men, with approximately 1 in 8 diagnosed during their lifetime. 2 mCRPC occurs when prostate cancer grows and spreads to other parts of the body despite hormone therapy that lowers testosterone. HRR gene mutations are present in approximately 20-30% of patients with mCRPC. 3 While treatment options have expanded in recent years, patients with mCRPC often continue to face poor prognosis and limited treatment options. 4 “Every patient deserves clear, personalized answers when it comes to their treatment plan, but one-size-fits all approaches do not work for everyone. As more targeted therapies become available to treat mCRPC, it is incredibly important to have high-quality tissue- and blood-based companion diagnostics available to best inform personalized treatment plans for each unique patient,” said Todd Druley, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. “These two approvals further strengthen Foundation Medicine’s leadership in companion diagnostics and underscore the critical role of comprehensive genomic profiling in connecting patients with targeted treatment options.” Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. 5 With this most recent approval, Foundation Medicine has nine FDA-approved companion diagnostic indications for prostate cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company. 1,6 “Too many prostate cancer patients still can’t access the biomarker tests that should guide their treatment, not because the tests don’t exist, but because access isn’t consistent or equitable,” said Courtney Bugler, President and CEO of ZERO Prostate Cancer. “Biomarker testing gives patients and their families the clarity they need to understand their diagnosis and make informed decisions about care. Every person deserves access to personalized treatment information, regardless of their doctor, their diagnosis, or their ZIP code.” About Foundation Medicine Foundation Medicine is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. We provide tests and solutions to transform care throughout a patient’s experience, from defining a diagnosis to determining the appropriate treatment to ongoing monitoring. We help accelerate the development of new personalized therapies by leveraging our vast knowledge of precision medicine, real world data and AI-powered tools, expanding the information our diagnostic solutions provide to enable improved outcomes for patients. Every day, we are inspired to think differently to transform the lives of people living with cancer and other diseases. For more information, visit us at and follow us on LinkedIn , X , YouTube , Facebook , Instagram and BlueSky . About FoundationOne®CDx FoundationOne®CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy which may pose a risk. For the complete label, including companion diagnostic indications and important risk information, please visit . About FoundationOne®Liquid CDx FoundationOne®Liquid CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes, rearrangements in 8 genes and copy number alterations in 3 genes, and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit . Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc. 1 Data on File, Foundation Medicine, Inc. 2025 2 Cancer.org. “American Cancer Society Key Statistics for Prostate Cancer.” January 2026. 3 de Bono J, et al. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28. PMID: 32343890. 4 Freedland SJ, Davis M, Epstein AJ, Arondekar B, Ivanova JI. Real-world treatment patterns and overall survival among men with metastatic castration-resistant prostate cancer (mCRPC) in the US Medicare population. Prostate Cancer Prostatic Dis 2024;27(2):327-33. 5 Data on File, Foundation Medicine, Inc., 2025 6 Data on File, Foundation Medicine, Inc., 2026 Contacts Holly Campbell, 480-213-8368 newsroom@foundationmedicine.com

Drug Approval

100 Deals associated with Entrectinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10926	Entrectinib	L01XE56	DB11986

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	South Korea	Roche Holding AG	21 Apr 2020
Reactive oxygen species 1 positive non-small cell lung cancer	United States	Genentech, Inc.	15 Aug 2019
NTRK fusion-positive solid tumors	Japan	Chugai Pharmaceutical Co., Ltd.	18 Jun 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Brain Cancer	NDA/BLA	China	Roche Holding AG	29 Oct 2021
Glioma	Phase 3	United Kingdom	-	30 Nov 2025
Hematologic Neoplasms	Phase 3	United Kingdom	-	30 Nov 2025
Lymphoproliferative Disorders	Phase 3	United Kingdom	-	30 Nov 2025
Melanoma	Phase 3	United Kingdom	-	30 Nov 2025
ROS1 fusion positive Neoplasms	Phase 3	United Kingdom	-	30 Nov 2025
ALK positive Non-Small Cell Lung Cancer	Phase 3	United States	F. Hoffmann-La Roche Ltd.	11 Jan 2023
ALK positive Non-Small Cell Lung Cancer	Phase 3	China	F. Hoffmann-La Roche Ltd.	11 Jan 2023
ALK positive Non-Small Cell Lung Cancer	Phase 3	Japan	F. Hoffmann-La Roche Ltd.	11 Jan 2023
ALK positive Non-Small Cell Lung Cancer	Phase 3	Australia	F. Hoffmann-La Roche Ltd.	11 Jan 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_SRC2026	Not Applicable	NTRK fusion-positive solid tumors NTRK fusion-positive	461	Entrectinib	yebwcmbrby(uakzkcziyp) = 23% cdhwfipxal (gfqrozxbbz ) View more	Positive	09 Mar 2026
ESMO2025	Not Applicable	Glioblastoma BRAFV600E mutation \| NRTK-fusion	25	Dabrafenib-trametinib	qcydsioxce(ptivhgsycf) = ttfdjeefto ldyzqevfcb (rmugnmgokg ) View more	Positive	17 Oct 2025
				Larotrectinib	qcydsioxce(ptivhgsycf) = znnuqgscvz ldyzqevfcb (rmugnmgokg ) View more
EANO2025	Not Applicable	Recurrent Malignant Glioma BRAFV600E mutation \| NRTK-fusion	25	Dabrafenib-trametinib	ubmvahxldj(owjamasihi) = jwrkgzrbad bjxcelwqfn (ooqfbtospy ) View more	Positive	16 Oct 2025
				Larotrectinib	qkjeygmxig(cybefdabvs) = ybpscjtxkt gckmizyoml (cinscvcipi ) View more
NCT02650401; NCT04589845; NCT02568267 (ASCO2025)	Not Applicable	-	113	Entrectinib	dwzbavdrfh(bnrdmebiem) = nytjelgwoe sjtjijepfl (rlacbdgyha, 48.2 - 85.7) View more	Positive	30 May 2025
NCT02568267 \| NCT02650401 \| NCT04589845 (STARTRK-NG, TAPISTRY, STARTRK-2, Pubmed \| Eur J Cancer)	Not Applicable	NTRK fusion-positive Central Nervous System Neoplasms NTRK \| ROS1	91	Entrectinib	deshuuaisa(mesvuqfhks) = muelgxmwky mjaehhtbxt (pcdfpttxkr, 57.2 - 85.0) View more	Positive	01 May 2025
				Placebo	deshuuaisa(mesvuqfhks) = ajjyzrafyp mjaehhtbxt (pcdfpttxkr, 40.8 - 84.6) View more
NCT05396859 (ASH2024)	Phase 1	Acute Myeloid Leukemia	-	Entrectinib	vjcxwaqmlv(umkntnlqcw) = 50% had grade 3+ treatment-related AEs, with 5 having grade 3 febrile neutropenia (4 of whom had active disease at time of onset) ryrlbiumhl (eulbfwvjds ) View more	-	07 Dec 2024
NCT02568267 \| NCT01945021 \| NCT02097810 (OxOnc, Pubmed \| Lung Cancer)	Not Applicable	Reactive oxygen species 1 positive non-small cell lung cancer ROS1-positive	179	Entrectinib	qxiedlzclx(kyornekwdy) = mpaxkmqghz cgjalhmwau (scixlaojdt, 28.3 - NR) View more	Positive	01 Dec 2024
				Crizotinib	qxiedlzclx(kyornekwdy) = uimtysryjk cgjalhmwau (scixlaojdt, 32.0 - NR) View more
NCT02568267 \| NCT02097810 (STARTRK-2, ESMO2024) Manual	Not Applicable	ROS1 fusion positive Neoplasms First line ROS1 fusion-positive	198	Entrectinib	uglblbbxcm(mxixqcaprs) = ouihzlzejg uhcwgegevt (rnjxlujdqk, 14.9 - 33.3) View more	Positive	14 Sep 2024
				Entrectinib (Baseline CNS mets)	uglblbbxcm(mxixqcaprs) = equdouudhr uhcwgegevt (rnjxlujdqk, 11.0 - 20.2) View more
NCT04226833 (CTgov)	Phase 1	Hepatic Insufficiency	38	entrectinib (Mild)	cuglkhkuet(koyazutjhy) = tcqkgurpfd qhnwseeofr (qorjermzof, 40.6) View more	-	02 Aug 2024
				entrectinib (Moderate)	cuglkhkuet(koyazutjhy) = qlngssiekt qhnwseeofr (qorjermzof, 36.7) View more
NCT03178552 (BFAST, Pubmed) Manual	Phase 2/3	Reactive oxygen species 1 positive non-small cell lung cancer First line ROS1 Positive	54	Entrectinib 600 mg	tqwwlitkyh(aspgseflmj) = ewavqrnxad wumkbekwrx (xebwqdssqh ) Met	Positive	19 Jun 2024

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis