FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

July 9, 2019 – The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions. 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. If approved … (leggi tutto)