Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

 Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

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

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: Fortune

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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