![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Merck’s Keytruda Nabs EU Approval for Colorectal Cancers
Merck’s Keytruda Nabs EU Approval for Colorectal Cancers
![Merck_logo.jpg](https://www.fdanews.com/ext/resources/test/Drug-Images4/Merck_logo.jpg?t=1576126512&width=430)
Merck’s blockbuster cancer drug Keytruda (pembrolizumab) has received European Commission approval as a standalone therapy for two types of colorectal cancer.
The approval is for first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer.
The commission based its approval on results from a pivotal phase 3 trial in which Keytruda as a standalone therapy reduced the risk of disease progression or death by 40 percent and “more than doubled median progression-free survival” compared with alternative therapies, the company said.
Merck earned almost $10.4 billion in global Keytruda sales for the first three quarters of 2020. Full-year 2020 sales data will be released Feb. 4.
Upcoming Events
-
21Oct