Novartis gets FDA OK for Tabrecta

Patients with a certain type of non-small cell lung cancer have a new treatment option.

The Food and Drug Administration has cleared Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping, or METex14 as detected by an FDA-approved test.

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.

The FDA also approved FoundationOne CDx as the companion diagnostic for Tabrecta, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue.

"NSCLC is a complex disease, with many different possible mutations that may encourage the cancer's growth," said Juergen Wolf, 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. 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 harboring this type of mutation."

"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, Novartis oncology president. "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."