Merck & Co. Reports the Resubmission of sBLA to the US FDA for Keytruda (pembrolizumab) Six-Week Dosing Schedule
Shots:
- The company resubmits the sBLA to the FDA for updating the dosing frequency for Keytruda- to include a 400mg dose infused over 30mis q6w- in addition to the currently approved dose of 200mg q3w
- Merck has filed the resubmission addressing the Complete Response Letter issued in Febr’2020 and filed sBLA across all indications of Keytruda- including monothx. and combination therapy
- Keytruda is a mAb blocks the interaction between PD-1 and its ligands- PD-L1 and PD-L2- thus activating T lymphocytes affecting both tumor cells and healthy cells
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Ref: Merck | Image: Merck
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