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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.