Pfizer holds exclusive rights to BRAFTOVI in the Middle East, Canada, Latin America, Africa, and the US. Credit: ShU studio/Shutterstock.

Pfizer has gained accelerated approval from the US Food and Drug Administration (FDA) for BRAFTOVI (encorafenib) in conjunction with cetuximab and mFOLFOX6 for treating metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, confirmed by an FDA-approved test.

This decision follows a significant improvement in response rate and durability response observed in the treatment-naïve subjects in the randomised, open-label, multicentre Phase III BREAKWATER trial that demonstrated an overall response rate of 61% with the BRAFTOVI regimen compared to 40% in the control arm.

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The ongoing active-controlled trial assesses the combination with or without mFOLFOX6 chemotherapy in previously untreated mCRC subjects with the BRAF V600E mutation.

FDA has granted this accelerated approval with the condition that further clinical benefits be verified for continued approval. This accelerated approval is part of the FDA’s Project FrontRunner, aimed at advancing cancer drug development.

Pfizer executive vice-president and chief oncology officer Chris Boshoff said: “For more than a decade, Pfizer has been a pioneer in delivering targeted therapies for molecular-driven cancers. With today’s accelerated approval of the BRAFTOVI regimen, patients with metastatic colorectal cancer with a BRAF V600E mutation now have a first-line treatment option, which contains a targeted therapy specifically for a mutation that is driving their cancer.

“This milestone adds to our legacy of developing innovative medicines in BRAF tumours, some of the hardest-to-treat cancers. We look forward to continuing to expand our portfolio, including the exploration of a next-generation brain-penetrant BRAF inhibitor.”

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Pfizer’s application for BRAFTOVI received priority review and utilised the Real-Time Oncology Review (RTOR) pilot programme.

Reviews are currently ongoing in Brazil and Canada, with discussions with other regulatory authorities globally to support additional licensing applications for the BRAFTOVI combination regimen.

In October 2023, the US regulator approved the combination of BRAFTOVI and Mektovi for treating metastatic non-small cell lung cancer (NSCLC).

Pfizer holds exclusive rights to BRAFTOVI in Canada, Latin America, the Middle East, Africa, and the US while Ono Pharmaceutical, Medison, and Pierre Fabre have rights in other specific territories.