FDA accepts another sBLA for Merck's Keytruda, following Imfinzi in biliary tract cancer
Merck announced Thursday morning that the FDA has accepted an sBLA for its sales kingpin and anti-PD-1 therapy Keytruda, setting a decision for early next year as the pharma attempts to follow AstraZeneca’s Imfinzi into yet another indication.
The application aims to get Keytruda approved as a combination treatment alongside chemotherapies gemcitabine and cisplatin in patients with locally advanced unresectable or metastatic biliary tract cancer and is based on a Phase III trial called KEYNOTE-966, where overall survival was higher in the treatment group by a statistically significant margin.
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