Novartis announced that it had received approval from the US Food and Drug Administration for Tabrecta (capmatinib, formerly INC280). The drug is indicated for metastatic NSCLC with a mutation that leads to MET exon 14 skipping.
The drug is an oral dosage form approved for adult patients.
The drug has received orphan, priority designation. The drug also received accelerated approval from the regulatory body. Further, it received the breakthrough designation.
The company reported that there is a high unmet need for the patients suffering from NSCLC with a mutation that leads to MET exon 14 skipping. There are 4,000 to 5,000 people in the US who are suffering from NSCLC with the mutation specified.
The drug has been approved based on mono-1 Phase II multi-center, non-randomized, open-label (GEOMETRY study). The overall response rate was 68% in treatment naïve patients and 41% in treatment-experienced patients. The median duration of response was 12.6 months in treatment naïve patients and 9.7 months in previously treated patients.
“Today, and especially during these difficult times, we are incredibly proud that Tabrecta is the first treatment approved by the FDA specifically to treat patients diagnosed with this aggressive NSCLC associated with METex14,” said Susanne Schaffert, Ph.D., President, Novartis Oncology. The product was initially developed by Incyte Corporation, which has provided development and commercialisation rights to Novartis. Also read: Trump administration takes first step in implementing provisional law to control drug prices