Sunday, 07 June 2020

FDA Approves Novartis Lung Cancer Drug, Tabrecta

13 May 2020 | News

MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14 is the first and only therapy approved by the FDA

Photo credit: theepharmatechnicians

Photo credit: theepharmatechnicians

Novartis announced on 6 May 2020 that the US Food and Drug Administration (FDA) approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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