Swissmedic Approves TEPMETKO® a Once-Daily Targeted Therapy for NSCLC with a METex14 Skipping Mutation1
News Release Merck (Schweiz) AG:
- TEPMETKO® is approved for both treatment naïve and previously treated metastatic NSCLC patients with METex14 skipping mutation1
- TEPMETKO® demonstrated consistent, rapid and durable responses regardless of treatment line, patient age, type of prior therapy, and presence of brain metastases 2
Zug, Switzerland, 22.06.2021 – Merck, a leading science and technology company, announced that Swissmedic has granted temporary authorization of TEPMETKO® (tepotinib) for the line agnostic treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping mutation.1
The approval is based on results from the pivotal Phase II VISION study evaluating TEPMETKO® as monotherapy in patients with metastatic NSCLC with METex14 skipping mutation.2 TEPMETKO® is administered once-daily as two 225 mg tablets (450 mg).1 TEPMETKO® is recommended as 1st line treatment for metastatic NSCLC with METex14 skipping mutation.3
The approval in Switzerland follows the approval in Japan in 2020 and in the U.S. earlier this year, where many patients are already benefiting from this new treatment option.
A Marketing Authorization Application for TEPMETKO® for a similar indication was validated by the European Medicines Agency in November 2020. The Swiss application was submitted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.4
About Non-Small Cell Lung Cancer
With over 2 million cases diagnosed annually worldwide, lung cancer is the second most common type of cancer and the leading cause of cancer-related death, with 1.8 million mortality cases each year.5 In Switzerland, 4500 new cases are diagnosed and 3200 patients die of lung cancer annually.6 METex14 skipping is a rare genetic mutation occurring in 3-4% of NSCLC2. As a result, TEPMETKO® was awarded Orphan Drug Designation by Swissmedic for the treatment of non-small cell lung cancer with MET alterations in January 2021.7
About TEPMETKO® (tepotinib)
TEPMETKO® is a selective and potent oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations.1 TEPMETKO® was discovered and developed in-house at Merck KGaA, Darmstadt, Germany.
For more information about TEPMETKO, please see full Prescribing Information.1
- Product Information Tepmetko, swissmedicinfo.ch Status 06.2021
- Paik et al. Tepotinib in Non–Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med 2020;383:931-943
- National Comprehensive Cancer Network. Non-Small Cell Lung Cancer (Version 3.2021). http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed June 2021
- US Food and Drug Administration. Project Orbis. US Food and Drug Administration. Project Orbis. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Online 06.2021
- Sung et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA Cancer J Clin 2021; 0: 1-41
- Schweizer Krebsliga, Zahlen und Fakten https://www.krebsliga.ch/ueber-krebs/zahlen-fakten/ online 06.2021
- Wichtige Arzneimittel für seltene Krankheiten (Orphan Drugs bei Humanarzneimitteln) https://www.swissmedic.ch/swissmedic/de/home/services/listen_neu.html#-257211596 online 06.2021
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of € 16.2 billion in 66 countries.
The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
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