FDA Approves Novartis Lung Cancer Drug, Tabrecta

May 7, 2020

Tabrecta is approved to specifically target metastatic non-small cell lung cancer with a mutation that leads to MET exon 14 skipping (METex14).

FDA has approved Novartis’ new lung cancer drug, Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for treating metastatic non-small cell lung cancer (NSCLC). The drug is specifically indicated for adult patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test, Novartis announced in a May 6, 2020 press release.

The indication was 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 confirmatory trial(s), according to Novartis. The drug is approved for first-line and previously treated patients, regardless of prior treatment type.

FDA has 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.

“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 Phase II study for Tabrecta, in the company press release. “MET exon 14 skipping is a known oncogenic driver. With today’s decision by [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 [FDA] specifically to treat patients diagnosed with this aggressive NSCLC associated with METex14,” said Susanne Schaffert, PhD, president, Novartis Oncology, in the press release. “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.”

Novartis was previously granted breakthrough therapy designation for capmatinib.

“With NSCLC, understanding whether a mutation is driving the cancer is critical, and it’s important for doctors and patients to use comprehensive biomarker testing at the time of diagnosis or progression to check for mutations like those that cause METex14,” added Andrea Ferris, president and CEO of LUNGevity, in the press release. “Knowing more about the molecular makeup of their tumor will help patients and their healthcare teams make informed treatment-related decisions from the start.”

Source: Novartis