Novartis Receives FDA Accelerated Approval for Lung-Cancer Treatment, Diagnostic

By Matteo Castia

Novartis AG said Thursday that the Food and Drug Administration has approved its lung cancer treatment Tabrecta and the associated diagnostic FoundationOne.

"This indication is 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 trials," the pharma giant said.

Tabrecta is a MET kinase inhibitor for adult patients with metastatic nonsmall cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping.

FoundationOne is a diagnostic that helps detecting mutations leading to MET exon 14 skipping in tumor tissue.

Write to Matteo Castia at matteo.castia@dowjones.com

(END) Dow Jones Newswires

May 07, 2020 01:47 ET (05:47 GMT)

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