FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

Source: OncLive, July 2019

The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.1 The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, and primary mediastinal large B-cell lymphoma.

For the sBLAs, the dosing schedule would be updated in the following indications:

 

read the original full article