Pfizer’s Braftovi (encorafenib) regimen has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat metastatic colorectal cancer (mCRC).
The drug has been authorised for use in combination with Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) to treat mCRC in patients with a BRAF V600E mutation.
Until now, there were no approved biomarker-driven therapies specifically indicated for patients with previously untreated BRAF V600E-mutant mCRC.
Colorectal cancer is the third most common type of cancer globally, with approximately 1.8 million new cases of the disease diagnosed in 2022. BRAF mutations are estimated to occur in up to 10% of patients with metastatic cases of the disease and are associated with a poor prognosis.
Braftovi is an oral small molecule kinase inhibitor designed to target the most common BRAF mutation, BRAF V600E. Pfizer has exclusive rights to the drug in the US, Canada, Latin America, the Middle East and Africa, while licences are also held by Ono Pharmaceutical, Medison and Pierre Fabre.
The FDA’s decision was supported by phase 3 results from the ongoing BREAKWATER trial in previously untreated mCRC patients with a BRAF V600E mutation.
The Braftovi regimen was associated with a statistically significant improvement over standard of care in one of the dual primary endpoints of confirmed overall response rate (ORR), with an ORR of 61% for Braftovi in combination with Erbitux and mFOLFOX6 versus 40% for chemotherapy, with or without bevacizumab.
The median duration of response was 13.9 months for the Braftovi combination regimen versus 11.1 months for chemotherapy, and the safety profile of the regimen was consistent with the known safety profile of each respective agent.
Chris Boshoff, chief oncology officer, executive vice president at Pfizer, said: “With [this] accelerated approval of the Braftovi regimen, patients with mCRC 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.”
In line with the FDA’s accelerated approvals pathway, continued approval is contingent upon the verification of clinical benefit.
The BREAKWATER data is also being discussed with other regulatory authorities globally to support potential future applications for the Braftovi combination regimen in this indication.