Pfizer Inc. said the U.S. Food and Drug Administration has granted priority review to an application seeking expanded use of Braftovi in combination with Eli Lilly and Co.'s Erbitux to treat a type of colon cancer.
The New York-based pharmaceutical giant is seeking approval of Braftovi with Erbitux, or cetuximab, for patients with BRAF-mutant colorectal cancer who have received either one or two prior therapies. This type of cancer starts in the colon and spreads to other parts of the body.
Colorectal cancer is the third and second most common type of cancer in men and women worldwide, respectively. According to estimates, the condition is responsible for about 50,000 deaths each year in the U.S., Pfizer said in a Dec. 18 press release.
Pfizer said the FDA designation is based on data from a phase 3 trial called Beacon CRC, which showed Braftovi, or encorafenib, in combination with either Mektovi and Erbitux or just Erbitux reduced tumor size and increased survival duration in patients with BRAF-mutant colorectal cancer.
The FDA is set to decide on the application by April 2020.
The U.S. regulator has already approved a combination of Mektovi, also called binimetinib, and Braftovi to treat skin cancer patients with a certain mutation in their BRAF gene whose cancer cannot be removed completely through surgery or has spread to other parts of the body.
Pfizer added Mektovi and Braftovi to its portfolio through the $11.4 billion acquisition of Boulder, Colo.-based cancer-drug maker Array BioPharma Inc.