regulatory approval
NICE Recommends Incyte's Pemazyre for FGFR2-Positive Bile Duct Cancer
The drug was approved in the UK for previously treated patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.
Merck's Keytruda Plus Chemo Approved in Europe for Certain Gastroesophageal Cancers
The European Commission approved the combination as first-line treatment for PD-L1-expressing advanced esophageal cancer or HER2-negative GEJ cancer.
BMS' Opdivo, Yervoy Combo Approved for dMMR, MSI-High Colorectal Cancer in Europe
The combination treatment has already been approved in the US and recommended for approval in the UK for this indication.
Chinese Regulators Approve Lynparza for BRCA1/2-Mutated mCRPC
China's NMPA granted conditional approval to AstraZeneca and Merck's PARP inhibitor in this setting based on the results of the PROfound trial.
FDA Approves Blueprint Medicines' Ayvakit for Advanced Systemic Mastocytosis
The approval was based on pooled data from Phase I and Phase II trials in advanced SM patients that showed an overall response rate of 57 percent.
Mar 30, 2021