Pfizer Gets FDA Priority Review of Braftovi/Erbitux in Colorectal Cancer
18 Dezembro 2019 - 01:21PM
Dow Jones News
By Colin Kellaher
Pfizer Inc. (PFE) 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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 18, 2019 11:06 ET (16:06 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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