New FDA approval Pfizer's Braftovi + Mektovi

The US Food and Drug Administration has approved US pharma giant Pfizer’s (NYSE: PFE) Braftovi (encorafenib) with Mektovi (binimetinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

The FDA said it has also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.

Pfizer gained rights to Braftovi + Mektovi along with its $11.4 billion acquisition of Colorado, USA-based biotech firm Array BioPharma in 2019.