Pfizer’s Braftovi (encorafenib) + Mektovi (binimetinib) Receives the US FDA’s Approval for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer
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- The US FDA has approved Braftovi + Mektovi for metastatic NSCLC with a BRAF V600E mutation. The approval was based on the P-II trial (PHAROS) of Braftovi + Mektovi in treatment-naïve & prior treated patients with BRAF V600E-mutant metastatic NSCLC
- The study met its major efficacy outcome measures of ORR & DoR. For treatment-naïve & previously treated patients, ORR (75% & 46%), and patients responded for 12mos. (59% & 33%), m-DoR was not estimable & 16.7mos. The results were presented at ASCO 2023 & published in the JCO
- Patients experienced an adverse reaction resulting in permanent discontinuation of Mektovi & Braftovi (17% & 16%) & serious adverse reactions (38%). Braftovi + Mektovi was approved in the US for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
Ref: Pfizer | Image: Pfizer
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
