Pfizer has secured the US Food and Drug Administration (FDA) approval for BRAFTOVI (encorafenib) in combination with cetuximab to treat a type of colorectal cancer (CRC).

The US regulatory agency has indicted BRAFTOVI plus cetuximab for the treatment of adult patients with metastatic CRC with a BRAFV600E mutation, detected by an FDA approved test, after prior therapy.

Pfizer holds exclusive rights to BRAFTOVI, an oral small molecule kinase inhibitor that targets BRAF V600E, in the US and Canada.

Pfizer oncology chief development officer Chris Boshoff said: “We are pleased by the FDA’s approval of BRAFTOVI in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers.

“We are grateful to the patients and study investigators who participated in the Phase 3 BEACON CRC trial and are proud to now be able to offer a targeted treatment option for people with BRAFV600E-mutant metastatic CRC who have received prior therapy. Looking ahead, we’re committed to continuing to investigate this treatment regimen across earlier lines of therapy.”

BRAFTOVI plus cetuximab showed positive results in BEACON CRC clinical trial

The pharmaceutical company said that the results from Phase 3 BEACON CRC clinical trial, involving patients with previously treated metastatic CRC with a BRAFV600E mutation, has supported the FDA approval.

The results from the BEACON CRC trial showed that BRAFTOVI plus cetuximab showed a superior median overall survival (OS), and improved objective response rate (ORR) in patients, compared to Control.

Fatigue, nausea, diarrhoea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash constitute the most common adverse reactions observed in patients treated with BRAFTOVI plus cetuximab.

University of Texas gastrointestinal medical oncology associate professor Scott Kopetz said: “BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients.

“As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic CRC who have received prior therapy, BRAFTOVI in combination with cetuximab is a much-needed new treatment option for these patients.”