FDA quietly turns Keytruda accelerated approval for less-frequent dosing into full approval

Merck’s anti-PD-1 antibody blockbuster Keytruda had a less-frequent dosing regimen previously cleared under an accelerated approval converted into full approvals on Dec. 16.

The accelerated approval was originally granted in 2020, and allowed for dosing of patients once every six weeks with 400 mg of the drug, as opposed to 200 mg every three weeks. The uses being converted to full approval include:

• The alternative dosing schedule for patients with a wide variety of cancer types including head and neck cancer, gastric cancer, melanoma and others
• The alternative dosing schedule for adult patients with metastatic or unresectable cancers with a high mutation burden in solid tumors
• The alternative dosing schedule for patients with cutaneous squamous cell carcinoma

The FDA’s approval letter to Merck noted that the full approval was given based on an analysis of overall response rate, duration of response, and safety from one of the cohorts of the KEYNOTE-555 trial, a Phase I randomized trial of pembrolizumab to evaluate bioavailability of the dosing regimen.

Scot Ebbinghaus

“The six-week dosing schedule for KEYTRUDA has provided physicians and patients with greater flexibility in their treatment plans. As part of our commitment to improving the lives of people living with cancer, we are excited that KEYTRUDA was granted a full approval for the six-week dosing option across solid tumors,” Merck clinical research VP Scot Ebbinghaus told Endpoints News via email.

A Merck spokesperson said that while the approval was converted, there is still one remaining for that dose regimen change in adult classical Hodgkin lymphoma and adult primary mediastinal large B cell lymphoma.

Editor’s note: This story was updated to clarify the description of how individual approvals are counted. 

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