FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14
pharmafile | May 7, 2020 | News story | Sales and Marketing | Incyte, Novartis, Tabrecta, pharma
The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta (capmatinib) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.
The decision, made under accelerated approval, was based on data demonstrating a confirmed overall response rate of 68% with Tabrecta in treatment-naïve METex14 patients and 41% in patients who had previously received treatment. In these same two populations, median duration of response was found to be 12.6 months and 9.7 months respectively.
“Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” commented Dr Juergen Wolf of University Hospital Cologne and lead investigator on the Tabrecta 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.”
Novartis holds exclusive development and commercialisation rights for the drug worldwide after acquiring them as part of a licensing agreement with Incyte in 2009. Under this partnership, this new approval will mean Incyte will be eligible to receive an agreed milestone payment of $70 million from the pharma giant, as well as 12-14% of the drug’s net sales in royalty payments.
“We are pleased that the FDA has approved Tabrecta for patients with METex14 NSCLC,” remarked Dr Steven Stein, Chief Medical Officer at Incyte. “Having a therapy that targets the recognized oncogenic driver will provide a much needed treatment option for patients with METex14 NSCLC who currently have limited treatment options. Tabrecta is the fourth Incyte molecule to be approved by the FDA, highlighting our world-class discovery programme and commitment to bringing innovative medicines to patients in need.”
Matt Fellows
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