Shots:
- The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w) vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a ratio (1:1) with r/r cHL who have failed ASCT or least two prior therapies when ASCT is not a treatment option
- Results: reduction in the risk of disease progression or death by 35%, median PFS (13.2mos. vs 8.3mos); ORR (66% vs 54%); DOR (20.7mos. vs 13.8mos.). The approval is also based on the KEYNOTE-087 trial
- The approval allows the marketing of Keytruda monothx. in all 27 EU member states includes Iceland, Lichtenstein, Norway, and Northern Ireland. Additionally, approval marks the first pediatric indication for Keytruda in the EU
Click here to read full press release/ article | Ref: Businesswire | Image: Law.com
The post Merck’s Keytruda (pembrolizumab) Receives the EC’s Approval in Adults & Pediatric patients with R/R cHL first appeared on PharmaShots.
