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FDA Approves Pfizer’s BRAFTOVI + MEKTOVI in NSCLC

Phase 2 PHAROS trial met its major efficacy outcome measures of objective response rate and duration of response.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pfizer received approval from the U.S. FDA for BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAF V600E mutations can be assessed from either plasma or tumor tissue using the FoundationOne Liquid CDx or the FoundationOne CDx FDA-approved companion diagnostic tests, respectively.   The FDA’s approval is based on data from the ongoing Phase 2 PHAROS clinical trial ...

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