Pfizer on Wednesday said the U.S. Food and Drug Administration accepted and granted priority review to a supplemental new drug application for Braftovi in combination with Erbitux in a form of colorectal cancer.
The New York drug maker said the agency set a target action date in April 2020.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Pfizer said the designation covers the combination in patients with advanced BRAF(V600E)-mutant metastatic colorectal cancer, following one or two lines of therapy.
The company said the designation is based on a phase 3 study that evaluated the efficacy and safety of the combination with or without Mektovi and showed improvements in overall survival and objective response rates for both compared to Erbitux plus irinotecan-containing regimens.
Pfizer has exclusive rights to Braftovi in the U.S. and Canada.
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