Health Canada Approves KEYTRUDA® for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy [Yahoo! Fin...
Merck & Company, Inc. (new) (MRK)
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Source: Yahoo! Finance
and Canada , announced that Health Canada has granted approval of KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with gemcitabine-based chemotherapy, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC). This approval is based on the results from the Phase 3 KEYNOTE-966 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone. "Biliary tract cancer is usually diagnosed at an advanced stage, where patient survival rates are poor," says André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "The addition of this indication shows promising overall survival results, which means more potential treatment options for biliary cancer patients in urgent need." About KEYNOTE-966 KEYNOTE-966 was a multicentre, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTr
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MRK
Earnings
- 4/25/24 - Beat
MRK
Sec Filings
- 5/15/24 - Form 424B5
- 5/15/24 - Form POSASR
- 5/6/24 - Form 144
- MRK's page on the SEC website