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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