FDA Accepts sBLAs for 6-Week Dosing Schedule of Pembrolizumab for Merkel Cell Carcinoma
Posted: Tuesday, July 16, 2019
The U.S. Food and Drug Administration (FDA) recently accepted for review six supplemental biologics license applications (sBLAs) to update the dosing frequency for pembrolizumab (Keytruda) to include an every-6-weeks dosing schedule option. Merck is seeking FDA approval of a 400-mg every-6-weeks dose infused over 30 minutes for pembrolizumab indications in Merkel cell carcinoma, melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, and hepatocellular carcinoma.
Pembrolizumab is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The recommended dose of pembrolizumab in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
If the every-6-weeks dosing schedule is approved by the FDA, it would be available for use in adults in addition to the currently approved dose of pembrolizumab at 200 mg every 3 weeks infused over 30 minutes. The FDA has set a target action date of February 18, 2020.
In the European Union, a 400-mg every-6-weeks dosing schedule for pembrolizumab monotherapy was approved by the European Commission in March 2019.
