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Speedy US approval for Novartis’ Tabrecta

Novartis’ Tabrecta (capmatinib, formerly INC280) has been awarded accelerated approval by the US Food and Drug Administration for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to MET exon 14 skipping (METex14).

The decision to grant accelerated clearance was based on overall response rate and duration of response, the drug giant said, but continued approval may be dependent on verification of these clinical benefits in confirmatory trials.

In the GEOMETRY mono-1 Phase II multicentre, non-randomised, open-label, multi-cohort study, the confirmed overall response rate was 68% and 41% among treatment-naive and previously treated patients, respectively.

In patients taking Tabrecta, the study also showed a median duration of response of 12.6 months in treatment-naive patients and 9.7 months in previously treated patients.

The most common treatment-related adverse events (AEs) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

According to Novartis, Tabrecta’s approval “fills a long-recognised and urgent need among METex14 patients who have not had a treatment option approved to specifically target the driver of their lung cancer”.

Physicians can now prescribe the drug for first-line and previously treated patients, regardless of prior treatment type as long as the relevant mutations have been detected by the FDA-approved companion diagnostic FoundationOneCDx.

“Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne and lead investigator of the GEOMETRY study.

“MET exon 14 skipping is a known oncogenic driver. We can now test for and treat this challenging form of lung cancer with a targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation.”