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

 ­ Ref: Businesswire | Image: Merck