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