[PRNewswire] European Medicines Agency Validates Application for Tepotinib
이 글자크기로 변경됩니다.
(예시) 가장 빠른 뉴스가 있고 다양한 정보, 쌍방향 소통이 숨쉬는 다음뉴스를 만나보세요. 다음뉴스는 국내외 주요이슈와 실시간 속보, 문화생활 및 다양한 분야의 뉴스를 입체적으로 전달하고 있습니다.
for the Treatment of Advanced NSCLC with METex14 Skipping Alterations
(DARMSTADT, Germany, Nov. 26, 2020 PRNewswire=연합뉴스) ㅜMerck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. With this validation, the application is complete, and the EMA will now begin the review procedure.
Tepotinib is a highly selective oral MET inhibitor that is administered once daily.[1] The application to the EMA is based on results from the pivotal Phase II VISION study (NCT02864992) evaluating tepotinib as monotherapy in patients with advanced NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy. In the ongoing study, the patient population is generally characterized as elderly, with a median age of 74.0 years, and as having poor clinical prognosis typical of NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were published in The New England Journal of Medicine (NEJM) [https://www.nejm.org/doi/full/10.1056/NEJMoa2004407 ] on May 29, 2020.[2]
Lung cancer is estimated to be the second most common cancer in Europe, and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018.[3] METex14 skipping occurs in approximately 3-4% of NSCLC cases and correlates with aggressive tumor behavior and poor clinical prognosis.[4] Currently, there are no treatments available in Europe for patients with advanced NSCLC harboring METex14 skipping alterations.
Tepotinib became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval globally, with its approval in Japan in March 2020 through the SAKIGAKE program. Recently, the FDA granted Orphan Drug Designation (ODD) to tepotinib and the FDA is reviewing the application under Priority Review and through the Real-Time Oncology Review pilot program.
About Tepotinib
Tepotinib is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck, it has a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.[1]
Additional Clinical Investigations: Tepotinib is also being investigated in the Phase II INSIGHT 2 study in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib, and in the Phase II PERSPECTIVE study in combination with cetuximab in RAS/BRAF wild-type left-sided metastatic colorectal cancer patients having acquired resistance to anti-EGFR antibody targeting therapy due to MET amplification.
References
1. Bladt F, et al. Clin Cancer Res. 2013;19:2941-2951.
2. Paik PK et al. Tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med 2020 May 29; [e-pub]. (https://doi.org/10.1056/NEJMoa2004407)
3. Ferlay J, et al. [https://www.nejm.org/doi/10.1056/NEJMoa2004407 ] Eur J Cancer. 2018;103:356-387 [https://www.ejcancer.com/article/S0959-8049(18)30955-9/fulltext ].
4. Reungwetwattana T, et al. Lung Cancer. 2017;103:27-37.
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
About Merck
Merck, 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 generated sales of € 16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Media Relations
gangolf.schrimpf@merckgroup.com
Phone: +49 6151 72-9591
Investor Relations
investor.relations@merckgroup.com
Phone: +49 6151 72-3321
Logo - https://mma.prnewswire.com/media/1136775/Merck_Logo.jpg
Merck Logo
Source: Merck
[편집자 주] 본고는 자료 제공사에서 제공한 것으로, 연합뉴스는 내용에 대해 어떠한 편집도 하지 않았음을 밝혀 드립니다.
(끝)
출처 : PRNewswire 보도자료
Copyright © 연합뉴스 보도자료. 무단전재 및 재배포 금지.
- '채상병특검법' 본회의 통과…野 재강행·與 반발에 정국 급랭(종합) | 연합뉴스
- 22대 국회 개원식 무기한 연기…'지각 신기록' 관측도(종합) | 연합뉴스
- 尹, 김홍일 사퇴 이틀만에 이진숙 지명…공영방송 이사교체 의지(종합) | 연합뉴스
- 시청역 역주행 운전자 "브레이크 밟았으나 딱딱했다"(종합) | 연합뉴스
- "누구도 못 몰아내"…바이든 후보 사퇴론 진화 '48시간 총력전' | 연합뉴스
- 손아카데미 학부모들 "한번도 체벌 없었다"…시민단체 "2차가해"(종합) | 연합뉴스
- 프로야구, 역대 최소 경기 600만 관중 돌파…12년 만의 신기록 | 연합뉴스
- 밤사이 시간당 20~30㎜ 호우…비구름대 빨라 강수시간 짧을 듯 | 연합뉴스
- 의대 증원 놓고 의평원-정부 충돌…'의대 인증' 새 변수 부상 | 연합뉴스
- "출생때부터 몸안 장기 없던 우리아이…의료공백에 내일 두려워" | 연합뉴스