FDA Accepts sBLAs for 6-Week Dosing Schedule of Pembrolizumab for Melanoma
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 melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma, and Merkel cell carcinoma.
Pembrolizumab is indicated for the treatment of patients with unresectable or metastatic melanoma. The recommended dose of pembrolizumab in patients with unresectable or metastatic melanoma is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
Pembrolizumab is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) after complete resection. The recommended dose of pembrolizumab for the adjuvant treatment of adult patients with melanoma is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease recurrence, unacceptable toxicity, or for up to 12 months in patients without disease recurrence.
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.