Pfizer has won expanded approval from the U.S. Food and Drug Administration of the combination of its Braftovi and Mektovi drugs for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.
The New York drugmaker on Thursday said the approval gives adults with BRAF V600E-mutant metastatic non-small cell lung cancer a new personalized treatment option.
Lung cancer is the leading cause of cancer death around the world, with non-small cell lung cancer accounting for more than 80%. A BRAF V600E mutation occurs in roughly 2% of non-small cell lung cancer cases, Pfizer said.
The Braftovi/Mektovi combination was previously approved in the U.S. for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Braftovi is also approved in combination with cetuximab for 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 in 2019.