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The FDA has approved FoundationOne® CDx and FoundationOne Liquid CDx for use as companion diagnostics to identify patients with metastatic non–small cell lung cancer harboring BRAF V600E mutations who may benefit from treatment with the combination of encorafenib plus binimetinib.
Braftovi (encorafenib) with Mektovi (binimetinib) has been approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, the agency announced on Wednesday evening.
Encorafenib plus binimetinib led to 75% ORR in untreated patients, 59% in treated patients
The single-arm approval study reported an objective response rate of 75% among treatment-naive patients.
The FDA companion diagnostic designation for FoundationOne CDx may improve access to niraparib/abiraterone acetate for eligible patients with metastatic castration-resistant prostate cancer (mCRPC) harboring a BRCA mutation.