Braftovi, an oral small molecule kinase inhibitor, has been developed to target BRAF V600E.
The approval was based on data from the BEACON CRC trial, which is claimed to be the only phase 3 trial to specifically assess patients with previously treated metastatic CRC with a BRAFV600E mutation.
According to the company, Braftovi plus cetuximab demonstrated a median overall survival (OS) of 8.4 months compared with 5.4 months for control.
The randomised, active-controlled, open-label, multicentre and phase 3 BEACON CRC trial was carried out at more than 200 investigational sites in North America, South America, Europe and the Asia Pacific region.
The study has been conducted by taking the support of Ono Pharmaceutical, Pierre Fabre and Merck KGaA.
With around 1.8 million new diagnoses in 2018, the colorectal cancer is said to be the most common type of cancer in men and the second most common in women.
Pfizer global product development chief development officer Dr Chris Boshof 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.”
Recently, Pfizer has collaborated with Biopharmaceutical New Technologies (BioNTech) for the co-development of a potential COVID-19 vaccine.
Under material transfer and collaboration agreement, the companies will co-develop and supply potential mRNA-based coronavirus vaccine for the prevention of COVID-19 infection.