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 after at least one multi-agent CT regimen
• Results: reduction in the risk of disease progression or death by 35%- median PFS (13.2mos. vs 3mos); ORR (66% vs 54%); DOR (20.7 mos. vs 13.8mos.). The approval is reviewed under the FDA’s Project Orbis
• Ketruda is a humanized mAb that blocks the interaction between PD-1 and its ligands- PD-L1 & PD-L2 thus activating T lymphocytes that affect tumor cells & healthy cells. Additionally- the US FDA has approved an updated pediatric indication for refractory cHL or cHL that has relapsed after two or more lines of therapy

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