US clears Pfizer's Braftovi, Mektovi combo for use in lung cancer

2023-10-12

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临床结果上市批准ASCO会议临床2期并购

Pfizer said Thursday that the FDA has approved Braftovi (encorafenib) plus Mektovi (binimetinib) to treat metastatic non-small-cell lung cancer (NSCLC) in adults with a BRAF V600E mutation. Initially approved by the FDA in 2018, the combination of Braftovi and Mektovi has "helped thousands of people living with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma BRAF V600E- or V600K-mutant unresectable or metastatic melanoma," remarked chief oncology R&D officer Chris Boshoff, adding "we look forward to helping even more patients with our…targeted combination therapy."

For the latest decision, US regulators reviewed data from the ongoing, single-arm Phase II PHAROS trial evaluating Braftovi plus Mektovi in 98 patients, including treatment-naïve and previously treated individuals, with BRAF V600E-mutant metastatic NSCLC. According to results presented earlier this year at the American Society of Clinical Oncology (ASCO) annual meeting, the study met its major efficacy outcome measures of objective response rate (ORR), with an ORR of 75% among treatment-naïve patients and 46% for those who have been previously treated.

Serious adverse reactions occurred in 38% of patients, with some of the more common events being haemorrhage, diarrhoea, anaemia, dyspnoea and pneumonia. Further, a total of 17% of patients experienced an adverse reaction that resulted in discontinuation of Mektovi, while 16% experienced an adverse event that resulted in stoppage of Braftovi.

Pfizer, which gained access to Braftovi and Mektovi through its $11.4-billion acquisition of Array Biopharma in 2019, has exclusive rights to both products in the US, Canada, and all countries in Latin America, Africa, and the Middle East. Meanwhile, Ono Pharmaceutical holds exclusive rights to sell both drugs in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific, not counting the territories covered by Ono.

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