Pfizer : FDA to Review Braftovi/Mektovi in Non-Small Cell Lung Cancer

By Colin Kellaher

Pfizer Inc. on Tuesday said the U.S. Food and Drug Administration has accepted for review applications seeking expanded approval of the combination of its Braftovi and Mektovi cancer drugs for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.

The New York drugmaker said the FDA set a target action date for a decision in the fourth quarter.

Lung cancer is the leading cause of cancer death around the world, with non-small cell lung cancer accounting for about 80% to 85% of cases. A BRAF V600E mutation occurs in roughly 2% of non-small cell lung cancer cases, Pfizer said.

The Braftovi/Mektovi combination is currently approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Braftovi is also approved in combination with cetuximab for the treatment of adults with metastatic colorectal cancer with a BRAF V600E mutation after prior therapy.

Pfizer picked up Braftovi and Mektovi as part of its $11.4 billion acquisition of Array BioPharma Inc. in 2019.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

04-04-23 0720ET