Merck Reports FDA’s Acceptance of sBLA of Keytruda (pembrolizumab) with Six-Week Dosing Schedule for Multiple Indications

Shots:

• The US FDA has accepted six sBLA for review to update dosing frequency of Keytruda (400 mg q6w) infused over 30mins. for multiple indications including melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma
• Post FDA’s approval, Keytruda (q6w) will be available for use in adults in addition to approved dose of Keytruda (200 mg, q3w) infused over 30 minutes with its expected PDUFA date as Feb 18, 2020
• Keytruda is a mAb, blocking the interaction b/w PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes affecting both tumor cells and healthy cells and has received EMA’s approval for its 400mg, q6w dosing on Mar 28, 2019

Click here to read full press release/ article | Ref: Merck | Image: Financial Times