Novartis capmatinib (INC280) received breakthrough designation by FDA
Updated: Apr 4
Novartis announced that capmatinib (INC280) received the breakthrough designation. The product is the first drug indicated for the first line and second-line treatment.
FDA gives breakthrough designation for the drugs which are indicated for serious or life-threatening disease. The therapies are expected to provide substantial benefit.
The drug received the breakthrough designation based on the GEOMETRY mono-1 study, which was presented in the American Society of Clinical Oncology (ASCO) 2019.
Capmatinib is a potent and selective MET inhibitor. MET mutation is identified in 3-4% of all the patients suffering from NSCLC.
The drug was originally developed by Incyte.
The drug is expected to release in Q4 of 2019.