NVS Novartis AG

By Michael Dabaie

Novartis said the U.S. Food and Drug Administration approved Tabrecta for adult patients with metastatic non-small cell lung cancer.

Novartis said the approval is for use by patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test.

Tabrecta is licensed to Novartis by Incyte Corp. Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

Incyte said the FDA approval of Tabrecta triggers $70 million in milestone payments from Novartis to Incyte. Incyte said it is also eligible to receive 12% to 14 % royalties on net sales of Tabrecta by Novartis.

Novartis said this indication is approved under accelerated approval based on overall response rate and duration of response.

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, Novartis said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

May 06, 2020 15:19 ET (19:19 GMT)

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