FDA extends date for review of Keytruda (pembrolizumab)for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. -Merck Inc.
Merck announced that the FDA has extended the action date for the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer.
The company recently submitted additional data and analyses to the FDA related to the pending application. The submission of additional data is considered a major amendment to the sBLA under the Prescription Drug User Fee Act (PDUFA), thus extending the target action date by three months. The new FDA target action date is 9 June 2017.
Comment; Microsatellite instability is a biomarker in certain kinds of cancer and is caused when a cell is not able to repair DNA sequencing errors (mismatch repairs), leading to more errors in microsatellite repeats after the cells divide.
Comment:MSI-H is seen in around 15% of patients with colorectal cancer.
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