Logo

Novartis and Incyte's Tabrecta (capmatinib- INC280) Receives the US FDA's Approval for Metastatic Non-Small Cell Lung Cancer with METex14

Share this

Novartis and Incyte's Tabrecta (capmatinib- INC280) Receives the US FDA's Approval for Metastatic Non-Small Cell Lung Cancer with METex14

Shots:

  • The approval is based on P-II GEOMETRY mono-1 study assessing Tabrecta (400mg- bid) in 97 patients with metastatic NSCLC harboring mutations that lead to METex14. The US FDA approved the therapy under accelerated approval based on ORR & DOR
  • The P-II study results: In treatment naïve & previously treated patients- ORR (68% & 41%); DOR (12.6 & 9.7mos.) respectively. Additionally- the FDA has approved FoundationOne CDx as the CDx for Tabrecta- to help in detecting mutations leading to MET exon 14 skipping in tumor tissue
  • Tabrecta (capmatinib) is a kinase inhibitor targeting MET- received the US FDA’s BT designation and is expected to be available to patients in the coming days. In 2009- Incyte granted Novartis WW exclusive development and commercialization rights to Tabrects and certain back-up compounds in all indications

Click here ­to­ read full press release/ article 

Ref: Novartis | Image: Novartis 


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions