RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Fast Track (Japan), Special Review Project (China)

Structure/Sequence

Molecular FormulaC29H31ClN6O3

InChIKeyKZVOMLRKFJUTLK-UHFFFAOYSA-N

CAS Registry1946826-82-9

Clinical Trials associated with Tepotinib Hydrochloride Hydrate

CTR20255027

/ Active, not recruitingNot Applicable

评估受试制剂盐酸特泊替尼片与参比制剂盐酸特泊替尼片（拓得康®）在餐后状态下作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study evaluating the effects of the investigational formulation terpoltinib hydrochloride tablets and the reference formulation terpoltinib hydrochloride tablets (Tordecan®) on healthy adult subjects in a postprandial state.

主要研究目的研究餐后状态下单次口服受试制剂盐酸特泊替尼片与参比制剂盐酸特泊替尼片（拓得康®）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盐酸特泊替尼片和参比制剂“拓得康®”在健康受试者中的安全性。

[Translation]

Primary Study Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation terpoxtinib hydrochloride tablets and the reference formulation terpoxtinib hydrochloride tablets (Tordecan®) in healthy adult subjects after a meal, and to evaluate the bioequivalence of the two formulations after an oral dose. Secondary Study Objective: To investigate the safety of the test formulation terpoxtinib hydrochloride tablets and the reference formulation "Tordecan®" in healthy subjects.

Start Date15 Jan 2026

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

CTR20255024

/ Active, not recruitingNot Applicable

评估受试制剂盐酸特泊替尼片与参比制剂盐酸特泊替尼片（拓得康®）在空腹状态下作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study evaluating the test formulation terpoltinib hydrochloride tablets versus the reference formulation terpoltinib hydrochloride tablets (Tordecan®) in healthy adult subjects under fasting conditions.

主要研究目的研究空腹状态下单次口服受试制剂盐酸特泊替尼片与参比制剂盐酸特泊替尼片（拓得康®）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盐酸特泊替尼片和参比制剂“拓得康®”在健康受试者中的安全性。

[Translation]

Primary Study Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation terpoxtinib hydrochloride tablets and the reference formulation terpoxtinib hydrochloride tablets (Tordecan®) in healthy adult subjects under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary Study Objective: To investigate the safety of the test formulation terpoxtinib hydrochloride tablets and the reference formulation "Tordecan®" in healthy subjects.

Start Date14 Jan 2026

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

NCT06908993

/ RecruitingPhase 3IIT

A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer

The hypothesize is that tepotinib is more effective than the investigator's choice of treatment in patients with MET-mutated NSCLC who have progressed after at least one first-line treatment.
The main benefit concerns patient access to tepotinib. There is currently no access to a new-generation MET TKI in France for METex14 patients, due to lack of comparative data. There are no phase III RCTs underway anywhere in the world. This study is the only opportunity, perhaps the last, to generate comparative data which, if positive, will enable the drug to be reimbursed. With this in mind, the methodology of this study was discussed with the HAS on several occasions beforehand, to ensure that it met their expectations. With a response rate of around 50% and a median progression-free survival of 11 months in previously-treated subjects based on clinical trials data, tepotinib is a key drug for METex14 NSCLC patients, who are generally elderly and frail, and for whom therapeutic options are limited.
The investigators expect to observe a benefit for patients treated with tepotinib compared to the control arm in terms of PFS, quality of life, objective response rate and duration of response. The overall survival benefit may be compromised by allowing patients in the control arm to cross over to tepotinib once they have progressed. However, the investigators have decided to maintain this crossover and consequently use PFS as the primary endpoint, as there is no clinical equipoise regarding the efficacy of tepotinib in METex14 NSCLC patients. The EMA has already approved tepotinib based on efficacy and safety data from clinical trials, and patients and investigators already consider this treatment as an important therapeutic option. Indeed, both ESMO and ASCO guidelines recommend the use of MET TKIs in these patients. In France, although neither tepotinib nor capmatinib are available, crizotinib, a multi-target TKI also active on MET, can be used off-label. If cross-over to tepotinib was not allowed in this trial, most patients would still benefit from cross-over to a MET TKI by receiving off-label crizotinib, which would in any case lead to a misinterpretation of the OS data. Therefore, the investigators believe it is preferable to control for cross-over and expose progressive patients in the control arm to tepotinib and use PFS as the primary endpoint.
Toxicity of MET TKIs is considered as manageable. In the VISION trial, of 313 patients treated with tepotinib (median age: 72 years), 109 (34.8%) experienced grade ≥3 treatment-related adverse events, leading to discontinuation in 46 patients (14.7%). Rates of adverse events (AE) were broadly consistent irrespective of prior therapies. Edema, the most common adverse event of clinical interest (AECI), was reported in 67.1% (grade ≥ 3, 11.2%). Median time to first edema onset was 7.9 weeks (range: 0.1-58.3). Edema was manageable with supportive measures, dose reduction (18.8%), and/or treatment interruption (23.1%), and rarely prompted discontinuation (4.3%). Other AECIs were also manageable and predominantly mild/moderate: hypoalbuminemia, 23.6% (grade ≥ 3, 3.5%); creatinine increase, 22.0% (grade ≥ 3, 1.0%); nausea, 23.3% (grade ≥ 3, 0.6%), diarrhea, 22.4% (grade ≥ 3, 0.3%), decreased appetite (grade ≥ 3, 0.3%), and ALT increase, 14.1% (grade ≥ 3, 2.2%). GI AEs typically occurred early and resolved in the first weeks10,13.
Given the efficacy of tepotinib, the manageable safety profile, and the oral administration of tepotinib, the investigators anticipate that treatment with tepotinib will be associated with improved quality of life.
Treatments offered in the control group correspond to standard treatments for advanced NSCLC in second line or beyond. In terms of prior lines of treatment, the eligibility criteria of the trial are aligned with the EMA label of tepotinib: "indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to MET gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy". The investigators have not included platinum-based chemotherapy as a treatment option in the control arm, considering that patients who are eligible to platinum-based chemotherapy should have received this regimen in first-line, as per ESMO guidelines14. Given the low efficacy of immunotherapy in patients with oncogene addiction, it is unlikely that some patients would receive immunotherapy alone as first-line treatment. Thus, the absence of platinum-based chemotherapy as a treatment choice in the control arm seems reasonable and will reduce the heterogeneity of this arm.

Start Date09 Dec 2025

Sponsor / Collaborator

Intergroupe Francophone Cancerologie Thoracique

100 Clinical Results associated with Tepotinib Hydrochloride Hydrate

100 Translational Medicine associated with Tepotinib Hydrochloride Hydrate

100 Patents (Medical) associated with Tepotinib Hydrochloride Hydrate

293

Literatures (Medical) associated with Tepotinib Hydrochloride Hydrate

31 Dec 2026·RENAL FAILURE

A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk

Article

Author: Bai, Zhixun ; Wang, Qin ; Zheng, Rubin ; Han, Jinfen ; Lyu, Jiayi ; Lu, Jing ; Deng, Miao ; Chen, Jiaxi

Proactive safety evaluation of molecularly targeted therapies requires generalizable frameworks that integrate real-world evidence with mechanistic insights. As a case in point, tepotinib, a mesenchymal-epithelial transition (MET) inhibitor for non-small cell lung cancer, has a known pulmonary toxicity profile, but its link to acute kidney injury (AKI) and underlying mechanism remain unclear. We devised a tri-scale in silico strategy encompassing population-scale pharmacovigilance signal extraction from the FDA Adverse Event Reporting System (FAERS) (2020-2025) via disproportionality analysis (Reporting Odds Ratio, ROR, and Proportional Reporting Ratio, PRR), network toxicology-based multi-target exploration for shared target and hub gene identification, and mechanistic docking-based molecular plausibility assessment using the Cavity-detection guided Blind Docking (CB-Dock2) platform. Pharmacovigilance analysis identified a significant renal impairment signal (ROR = 20.60). Network toxicology suggested potential nephrotoxicity and revealed 173 shared targets and prioritizing six hub genes (HSP90AA1, AKT1, EGFR, CASP3, TNF, SRC). These genes were shown to be critically involved in PI3K-Akt and MAPK pathways. Molecular docking revealed high-affinity binding between tepotiniband all six hub targets (Vina scores: -8.0 to -10.6 kcal/mol), providing a structural basis for the postulated mechanistic link to AKI. These findings not only highlight the necessity for enhanced renal monitoring in tepotinib-treated patients but, more broadly, establish the FAERS-NetDock Pipeline as a reusable, generalizable and hypothesis-generating framework for evaluating tyrosine kinase inhibitors (TKIs)-induced nephrotoxicity; this framework is immediately applicable to profiling the safety of other TKIs (e.g. crizotinib, capmatinib, savolitinib, afatinib and osimertinib) and is readily adaptable for de-risking a wider spectrum of targeted therapies.

01 Apr 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Real-world evidence for 10 oncology drugs approved in the last 5 years: A comprehensive narrative synthesis

Review

Author: Oggionni, Emanuela ; Balconi, Elena ; Parati, Maria Chiara ; Rossitto, Mauro ; Petrò, Daniela ; Petrelli, Fausto ; Ghilardi, Mara ; Colombo Zefinetti, Lara ; Dottorini, Lorenzo ; Borgonovo, Karen ; Castelli, Emanuela ; Dognini, Giuseppina ; Zambelli, Alberto

IMPORTANCE:

Randomized controlled trials (RCTs) establish the efficacy of new oncology drugs but often exclude older adults, patients with comorbidities, and individuals with poorer performance status. Real-world evidence (RWE) is therefore essential to determine whether trial benefits translate to the broader populations treated in routine practice.

OBJECTIVE:

To synthesize contemporary RWE on the effectiveness and safety of ten oncology drugs approved between 2020 and 2025 for solid tumors, focusing on studies with ≥ 100 patients to maximize robustness and generalizability.

EVIDENCE REVIEW:

A systematic search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and major conference proceedings (ASCO, ESMO, AACR) identified observational cohorts, registries, expanded-access programs, and claims-based studies published from January 2020 to January 2025.

FINDINGS:

Twenty studies (N > 3400) met inclusion criteria: breast cancer (9), lung cancer (7), urothelial carcinoma (3), and endometrial cancer (1). In breast cancer, sacituzumab govitecan reproduced ASCENT outcomes (ORR 27-30 %; PFS 4.8-5.2 months), trastuzumab deruxtecan achieved ORRs near 70 % in HER2-positive disease and median PFS 7.5 months in HER2-low cohorts, and elacestrant showed real-world time-to-next-treatment of 7.9-10.8 months in ESR1-mutant ER+ /HER2 - disease. In NSCLC, sotorasib and adagrasib demonstrated ORRs of ∼28-34 % and PFS 3.5-6 months, selpercatinib provided durable disease control, and MET inhibitors (capmatinib, tepotinib) yielded PFS around 6-7 months. In urothelial carcinoma, enfortumab vedotin produced ORRs of 31-73 % across datasets. In endometrial cancer, dostarlimab generated highly durable responses in dMMR/MSI-H disease.

CONCLUSIONS:

RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs.

01 Feb 2026·EUROPEAN JOURNAL OF CANCER

Targeting driver mutations in lung cancer with interstitial pneumonia: A nationwide study in Japan

Article

Author: Tanino, Yoshinori ; Waseda, Yuko ; Inomata, Minehiko ; Amimoto, Hisanori ; Ogura, Takashi ; Yamauchi, Hiroyoshi ; Ichikado, Kazuya ; Ikeda, Satoshi ; Kinoshita, Yoshiaki ; Hashimoto, Naozumi ; Ozasa, Hiroaki ; Nakamura, Yutaro ; Hashimoto, Seishu ; Murakami, Koji ; Itoh, Taku ; Karayama, Masato ; Kato, Motoyasu ; Isshiki, Takuma ; Sakamoto, Noriho ; Nishioka, Yasuhiko ; Kishi, Kazuma ; Yanagihara, Toyoshi ; Okishio, Kyoichi ; Fukuizumi, Aya ; Nishikiori, Hirotaka ; Sato, Yuki ; Honda, Takayuki ; Kishaba, Tomoo ; Ishida, Yuriko ; Koyama, Junji ; Tsurumaki, Nozomu ; Tamura, Kentaro ; Yamaguchi, Kakuhiro ; Miyamoto, Atsushi ; Yamane, Mayuka ; Takata, Saori ; Kikuchi, Ryota ; Misumi, Toshihiro ; Yatera, Kazuhiro ; Matsumoto, Masaru

INTRODUCTION:

Non-small cell lung cancer (NSCLC) patients with comorbid interstitial pneumonia (IP) are at high risk for drug-induced pneumonitis, and previous reports suggest a lower frequency of common driver mutations such as EGFR. This may discourage genetic testing, potentially overlooking prevalent, targetable mutations like KRAS, BRAF, and MET. This study aimed to elucidate the real-world status of genetic testing, the frequency of oncogenic drivers, and the safety and efficacy of targeted therapies in patients with NSCLC and comorbid IP.

METHODS:

This multicenter, retrospective study analyzed 1256 patients with advanced or recurrent NSCLC and comorbid chronic fibrosing IP from 37 Japanese institutions (Registry number: UMIN000055609).

RESULTS:

The rate of any genetic testing was 59.2 % (95 % confidence interval [CI], 56.5-62.0), with multigene testing performed in only 41.0 % (95 %CI, 38.3-43.8). Among patients with NSCLC undergoing multigene testing (N = 515), the most frequent mutations were KRAS (4.7 %; G12C, 1.9 %), followed by EGFR (2.9 %), BRAF V600E (1.6 %), and MET exon 14 skipping (1.6 %). The incidence of drug-induced pneumonitis was 0 % (0/6) for sotorasib, 50 % (4/8) for osimertinib, 33 % (1/3) for alectinib, and 25 % (1/4) for both dabrafenib plus trametinib and tepotinib. Patients with actionable oncogenic drivers receiving targeted therapy had the longest overall survival, followed by those not receiving it, and then driver-negative/unknown patients (median: 39.2, 24.0, and 13.8 months, respectively).

CONCLUSIONS:

Multigene testing is underutilized in this population. While many targeted therapies carry a high risk of pneumonitis, sotorasib appeared relatively safe. Despite the risks, identifying and treating actionable oncogenic drivers may improve survival.

News (Medical) associated with Tepotinib Hydrochloride Hydrate

10 Mar 2026

·www.biospace.com

Foundation Medicine Announces Expanded Participation in National Cancer Institute’s ComboMATCH Platform Trials Through Inclusion of Its High-Quality Blood-Based Biomarker Test, FoundationOne®Liquid CDx

Foundation Medicine remains one of the chief contributors to ComboMATCH, the largest of its kind initiative to test effectiveness of biomarker-targeted cancer treatment combinations BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced its expanded participation with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) in the Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH). 1 The initiative now includes the high-quality blood-based biomarker test, FoundationOne®Liquid CDx, to test new therapy combinations in select groups of adults and children with cancer. NCI is part of the National Institutes of Health. In 2023, Foundation Medicine began its participation in ComboMATCH through inclusion of its high-quality tissue-based biomarker test, FoundationOne®CDx. Foundation Medicine is a participating Designated Laboratory in the initiative, meaning that oncologists at ComboMATCH clinical sites may utilize their patients' prior commercial testing results from FoundationOne CDx and now, FoundationOne Liquid CDx, to help determine their eligibility for ComboMATCH treatment trials. The initiative aims to identify promising treatments that can advance to larger, more definitive clinical trials outside of ComboMATCH and improve patient outcomes. Each selected combination has strong pre-clinical or clinical evidence that it could be more effective than either of the single agents alone. ComboMATCH tests whether therapy selected in this manner to treat cancer may provide better patient outcomes than the current standard of care. “The more we learn about how different cancers work and respond to treatment, the faster new targeted treatments and combinations can become available,” said Foundation Medicine’s Vice President, Head of Clinical Development, Amaya Gascó, M.D., Ph.D. “By using results from high quality biomarker tests like FoundationOne CDx and FoundationOne Liquid CDx to help determine trial eligibility for patients, ComboMATCH is connecting patients to the right trials for their unique cancer and informing more precise therapy options for complex cases to help improve patient outcomes.” Since ComboMATCH opened, Foundation Medicine has been a key contributor to the initiative by facilitating patient screening and enrollment through results from its high-quality biomarker tests. From 2017 to 2023, Foundation Medicine was also involved in the NCI’s MATCH study, a precursor to ComboMATCH, which evaluated the benefit of genomically-guided treatments targeting specific alterations within a patient’s tumor, regardless of cancer type. Foundation Medicine was the top designated laboratory to facilitate trial enrollment to the MATCH study, which helped the NCI and other partners cast a wide net to evaluate patients who might have been eligible for treatment. For individuals interested in joining a ComboMATCH treatment trial, the first step is to enroll in the patient registration trial through their oncologist. This protocol, managed by ECOG-ACRIN, contains the rules for assigning patients to various treatment trials and other guidelines. Patients' tumor test results must show abnormalities being targeted by the drug combinations in the study. During registration, a patient's oncologist will review the FoundationOne CDx or FoundationOne Liquid CDx test results, along with other clinical information, to determine if they are eligible for one of the treatment trials. ComboMATCH treatment trials are conducted under an NCI-sponsored Investigational New Drug Application, and led by NCI network groups in the U.S. The groups are the Alliance for Clinical Trials in Oncology, Children’s Oncology Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG Cancer Research Network. Many pharmaceutical companies are providing their agents for evaluation in these treatment trials. Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc. 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 . 1 National Cancer Institute. . Posted June 1, 2023. Referenced January 13, 2026. Contacts Media Contact: Abigail Linehan, 781-534-3210 newsroom@foundationmedicine.com

Clinical Study

03 Sep 2025

·pharma.economictimes.indiatimes.com

GST waiver for 36 drugs; formulations under 5% slab

New Delhi: Executing the much-awaited overhaul of the Goods and Services Tax (GST) regime, the GST Council has brought a major relief for patients by reducing the indirect tax on medicines to 5 per cent, along with exempting as many as 36 life-saving medicines and other critical drugs. The GST council—a statutory body highest decision making body on indirect taxes led by the Union Finance Ministry at its 56th meeting in the national capital has recommended to reduce the GST on all drugs and medicines (finished formulations) from 12 per cent to 5 per cent under the new two-tier tax structure of 5 and 18 per cent slabs to be effective from September 22. Additionally the body has also recommended to exempt GST on 33 lifesaving drugs and on 3 other medicines used for treatment of cancer, rare diseases and other severe chronic diseases. Speaking at a press briefing after the council 10.5-hour long marathon meet, Finance Minister Nirmala Sitharaman said, “all recommendations have been cleared with zero reservations and have corrected various inverted duty structure problems, classification related issues and that this rationalization exercise will bring predictability and stability of GST.” “These reforms have been carried out with a focus on the common man, and after a rigorous evaluation process in most sectors including healthcare, the rates have come down drastically, she added. Previously, medicines in India were taxed at 5 per cent for life-saving and essential drugs, and at 12 per cent for others but following the announcement all medicines will attract a standard duty of 5 per cent with extensions for several medicines specified at the end of this article. Welcoming the move, Sudarshan Jain, Secretary General, IPA said, “the decision to exempt life-saving and cancer medicines from GST, is a step that will bring direct relief to patients and their families. and, the reduction in GST on a wide range of medicines from 12 per cent to 5 per cent will further help to ease the overall treatment burden and make essential therapies more affordable.” Meanwhile, for companies, the clarity on a 5 per cent slab and exemptions removes long-standing ambiguity, enabling transparent pricing and better market planning. The move will expand access in semi-urban and rural markets, ease litigation, and free up resources for innovation, said Manoj Mishra, Partner and Tax Controversy Management Leader, Grant Thornton Bharat LLP. Notably, on the issue of inverted duty involving APIs and key starting materials—which are currently taxed at 18 per cent against 12 or 5 per cent for finished formulations—further clarity is awaited from the industry. ETPharma earlier reported that, in a letter to the Finance Minister, the national chemist body, the All India Organisation of Chemists and Druggists (AIOCD) had urged, “to bring all medicines including vitamins, probiotics, nutritional, food supplements under the 5 per cent GST slab. The rate rationalization comes days after Prime Minister Narendra Modi had pitched for introducing next-gen reforms across sectors to “increase ease of living for the common man and strengthen the economy.” However, this rationalization brings a revenue shortfall challenge for governments with states likely to bear a greater share of the burden, as they receive over 40 percent of the inter-state inflows in addition to their own SGST collections. Responding to a media query at the media briefing Arvind Shrivastava, Revenue Secretary said that, based on the consumption of FY23-24 the ministry has estimated that the net revenue implication of this proposal will be around Rs 48,000 crore. “However the exercise will trigger buoyancy effects and will have a positive impact on consumer and compliance. And therefore we believe this proposal will be fiscally sustainable both for centers and the states,” Shrivastava noted. ' S.no. Drug Indication Brand name and (Company) 1 Onasemnogene abeparvovec SMA (One-time gene therapy) Zolgensma (Novartis) 2 Asciminib Blood Cancer Scemblix (Novartis) 3 Mepolizumab Asthma Nucala (GSK) 4 Pegylated Liposomal Irinotecan Pancreatic Cancer Onivyde (Ipsen) 5 Daratumumab Cancer Darzalex (J&J subsidiary) 6 Daratumumab subcutaneous Cancer Darzalex Faspro (J&J subsidiary) 7 Teclistamab Blood Cancer Tecvayli (J&J subsidiary) 8 Amivantamab Lung Cancer Rybrevant (J&J subsidiary) 9 Alectinib Lung Cancer Alecensa (Roche) 10 Risdiplam SMA Evrysdi (Roche) 11 Obinutuzumab Blood Cancer Gazyva (Roche) 12 Polatuzumab vedotin Blood Cancer Polivy (Roche) 13 Entrectinib Cancer Rozlytrek (Roche) 14 Atezolizumab Cancer (PD-L1 immunotherapy) Tecentriq (Roche) 15 Spesolimab GPP flares Spevigo (Boehringer Ingelheim) 16 Velaglucerase Alpha Gaucher Vpriv (Takeda) 17 Agalsidase Alfa Fabry disease Replagal (Takeda) 18 Rurioctocog Alpha Pegol Hemophilia Adynovate (Takeda) 19 Idursulphatase Type II Mucopolysaccharidosis Elaprase (Takeda) 20 Alglucosidase Alfa Pompe Myozyme (Sanofi) 21 Laronidase Type I Mucopolysaccharidosis Aldurazyme (Sanofi) 22 Olipudase Alfa ASMD Xenpozyme (Sanofi) 23 Tepotinib Lung Cancer Tepmetko (Maerck KGaA) 24 Avelumab Cancer (PDL-1 immunotherapy) Bavencio (Pfizer) 25 Emicizumab Hemophilia Hemlibra (Roche subsidiary) 26 Belumosudil cGVHD - 27 Miglustat Gaucher Zavesca (J&J subsidiary) 28 Velmanase Alfa Alpha-mannosidosis - 29 Alirocumab Cholesterol lowering drug (LDL-C) Praluent (Sanofi) 30 Evolocumab Cholesterol lowering drug (LDL-C) Repatha (Amgen) 31 Cystamine Bitartrate Cystagon - 32 CI-Inhibitor injection Hereditary Angioedema - 33 Inclisiran Cholesterol lowering drug (LDL-C) Leqvio (Novartis) 34 Agalsidase Beta Fabry disease Fabrazyme (Sanofi) 35 Imiglucerase Gaucher Cerezyme (Sanofi) 36 Eptacog alfa activated recombinant coagulation factor VIIa Hemophilia NovoSeven Note: Above is the list of medicines exempted from GST tax recommended by the 56th GST Council Meet/ Source: PIB By Abhijeet Singh ,

Gene Therapy

31 Mar 2025

·www.echemi.com

Merck and Roche Join Forces for Tepotinib Commercialization in China

On March 26, 2025, Merck and Roche Pharmaceuticals officially announced a strategic partnership aimed at accelerating the commercialization of Tepotinib (brand name: Togetican®) in the mainland Chinese market. Industry analysts suggest that Merck is leveraging Roche's distribution network in China to expedite the launch of this groundbreaking drug. Tepotinib is the world's first approved MET inhibitor, developed by Merck in Germany. It is an oral, highly selective MET tyrosine kinase inhibitor designed to block cancer signaling pathways caused by MET gene mutations. The drug received approval in Japan in March 2020 for treating patients with unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. In February 2021, Tepotinib gained accelerated approval from the FDA for treating adult patients with metastatic NSCLC who also have these mutations. In December 2023, the drug was officially approved for use in mainland China, targeting locally advanced or metastatic NSCLC patients with MET exon 14 skipping mutations. It was included in the national health insurance catalog by the end of 2024, with implementation starting January 1, 2025. Clinical trials have validated Tepotinib's efficacy, demonstrating its high selectivity and good tolerability, particularly in Asian populations. The drug has received endorsements from prestigious guidelines like NCCN and CSCO. Currently, several MET inhibitors have received global approval, including: Capmatinib (developed by Novartis), which was approved by the FDA in May 2020 as the first targeted therapy for MET exon 14 skipping mutations in NSCLC. In clinical trials, it showed an objective response rate (ORR) of 67.9% in treatment-naive patients. Savolitinib (developed by Hutchison China MediTech), the only MET inhibitor approved in China, also demonstrated encouraging efficacy in patients with MET exon 14 skipping mutations. However, Tepotinib will face competition from domestic MET inhibitors such as Gumetinib from Allergan, which is currently in late-stage clinical trials and could enter the market at a lower price point. Lung cancer remains a leading cause of morbidity and mortality globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85%-90% of cases. The incidence of MET exon 14 skipping mutations in NSCLC patients is about 1%-4%, which, while relatively rare, translates to a significant number of patients given the large patient population and limited treatment options. This partnership is pivotal for Roche, enabling it to expand its footprint in lung cancer treatment. By incorporating Tepotinib into its portfolio, Roche enhances its competitive edge in the precision treatment market for lung cancer, moving beyond its existing focus on ALK and NTRK/ROS1 mutations. Merck's expertise in drug development and innovation combined with Roche's rich experience in commercialization will likely bolster Tepotinib's market competitiveness, promising substantial commercial value for both companies. The success of this collaboration could set a new benchmark in the treatment of lung cancer.

Drug Approval

100 Deals associated with Tepotinib Hydrochloride Hydrate

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KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB15133

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	South Korea	Merck & Co., Inc.	23 Nov 2021
Non-Small Cell Lung Cancer	United States	EMD Serono, Inc.	03 Feb 2021
c-Met positive non-small cell lung cancer	Japan	Merck KGaA	25 Mar 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	United States	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Belgium	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Czechia	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	France	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Italy	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Russia	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Spain	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	United Kingdom	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
Advanced Malignant Solid Neoplasm	Phase 2	South Korea	Merck KGaA	16 Jan 2020
Breast Cancer	Phase 2	South Korea	Merck KGaA	16 Jan 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ASIA2025	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET exon 14 skipping mutations	55	Tepotinib	hokcvkedem(hxlbgfyzyj) = jpvvoqskiu hbztcwuzko (rgcuwbonlr ) View more	Positive	05 Dec 2025
				Tepotinib (1L)	hokcvkedem(hxlbgfyzyj) = kshjdjasze hbztcwuzko (rgcuwbonlr ) View more
ESMO_ASIA2025	Not Applicable	MET gene amplification Non-small Cell Lung Cancer MET gene copy number	16	Tepotinib	szlsulampn(buvxwnzkxy) = dssuxqlkol bgttxeolje (rtpffskkij, 2 - 26) View more	Positive	05 Dec 2025
				Tepotinib	szlsulampn(buvxwnzkxy) = pqjifssgbw bgttxeolje (rtpffskkij, 3 - 24) View more
REAL-MET (ESMO2025)	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET exon 14 skipping	62	Tepotinib (Brain Metastases)	rwkgknhbnz(gxpmxfmase) = gdmsquumfh mjupzfizyf (jaziakvwpu ) View more	Positive	17 Oct 2025
				Tepotinib (No Brain Metastases)	qcygkaetln(xgesyanhrv) = frcdlxljkr hvdijghoda (pphtabvgkj, 1.7 - 12.1) View more
VISION study (ASCO2025)	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line PD-L1	98	Tepotinib	pasuuezpdj(elyxsaxgfl) = Grade 3 or higher edema occurring in 12.9% of the patients qqixsmpcrb (lhmefbwmds )	Positive	30 May 2025
				Immune Checkpoint Inhibitors
NCT02864992 (VISION study, ESMO_ELCC2025)	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line METex14 skipping \| METamp	313	Tepotinib 500 mg	tuywzvdbxm(fibillcunj) = 15.7% of pts discontinued treatment due to TRAEs lwdxyhrmxb (ucdjqkqycs ) View more	Positive	26 Mar 2025
NCT03940703 (INSIGHT 2, Pubmed \| Lancet Oncol) Manual	Phase 2	Non-Small Cell Lung Cancer Second line EGFR Mutation \| MET Amplification	128	Tepotinib plus osimertinib (progression on first-line osimertinib)	qeezvwkiqz(ngtuivylkz) = ishgdwjjic gnwikuwiwf (qggzfuzfdb, 39.7 - 60.3) View more	Positive	25 Aug 2024
NCT03546608 (CTgov)	Phase 1	Hepatic Insufficiency	18	Tepotinib (Healthy Participants (Control))	omjbgkimei(oggyupylok) = qmgseeqerq cfyydxjmdf (yljjnpubjl, 13.4) View more	-	12 Aug 2024
				Tepotinib (Mild Hepatic Impairment (Child-Pugh Class A))	omjbgkimei(oggyupylok) = sldxemnwou cfyydxjmdf (yljjnpubjl, 63.9) View more
NCT03940703 (INSIGHT 2, CTgov)	Phase 2	Recurrent Non-Small Cell Lung Cancer	140	Tepotinib (Tepotinib Mono-therapy)	sanueqpizi(bkaflhyhbi) = biamilxwfu svkihhpjlp (nzsoijxmoh, qvbuevpdge - dcdqlytqml) View more	-	04 Jun 2024
				Tepotinib+Osimertinib (Tepotinib and Osimertinib)	sanueqpizi(bkaflhyhbi) = gahucbrmgb svkihhpjlp (nzsoijxmoh, oxtnocsnlk - oziwdnajrs) View more
NCT02864992 (VISION, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer \| MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping	248	tepotinib (Brain metastases)	cjlneqcgnw(hlaimrxbid) = zgtqjjbrza kmcgtrqzvz (felqtfmuxj, 2.41) View more	Positive	24 May 2024
				tepotinib (Liver metastases)	cjlneqcgnw(hlaimrxbid) = xmxngieico kmcgtrqzvz (felqtfmuxj, 2.27) View more
NCT04647838 (KCSG AL19-17, ASCO2024)	Phase 2	Hepatocellular Carcinoma \| Solid tumor \| Neoplasm Metastasis ... ctDNA \| METex14 \| METamplification ... View more	35	Tepotinib	xgbeozbbbx(fequbeqxpi) = erxecsqtlm omfozsmvej (xpwkqtkter ) View more	Positive	24 May 2024
				Placebo	xgbeozbbbx(fequbeqxpi) = fotqibebpf omfozsmvej (xpwkqtkter ) View more

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