FDA approves Tabrecta for treatment of metastatic non-small cell lung cancer

Novartis has announced that the US Food and Drug Administration (FDA) has approved Tabrecta^™ (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test.

The company was previously granted Breakthrough Therapy Designation for capmatinib. The drug is a kinase inhibitor that targets MET in a tablet formulation. 

Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type, and is expected to be available to patients in the coming days.

“NSCLC is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” said Dr Juergen Wolf, from the Center for Integrated Oncology, University Hospital Cologne. “MET exon 14 skipping is a known oncogenic driver. With today’s decision by the FDA, we can now test for and treat this challenging form of lung cancer with a targeted therapy, offering new hope for patients with NSCLC harbouring this type of mutation.”

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 Phase II multi-centre, non-randomised, open-label, multi-cohort study. In the METex14 population, the confirmed overall response rate was 68 percent and 41 percent among treatment-naive and previously treated patients, respectively. 

“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 Dr Susanne Schaffert, President of Novartis Oncology. “In our quest to reimagine medicine, we have worked tirelessly over the past decades to advance the understanding and treatment of NSCLC, striving to make a difference in patients’ lives, one mutation at a time. We thank all the physicians, patients and families involved in the Tabrecta clinical trials and we remain committed to advancing innovative solutions for the patients we work to serve.”