FDA Approves New 6-Week Dosing for Keytruda for All Approved Adult Indications from Biospace.com

  • News

Merck’s vaunted checkpoint inhibitor Keytruda has picked up another regulatory approval. The U.S. Food and Drug Administration (FDA) approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.

Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, said the latest dosing approval is beneficial to cancer patients especially during the COVID-19 pandemic when social distancing has become an essential tool in limiting the spread of the disease. But, that social distancing has become a challenge, particularly for oncology patients who are dependent upon visiting their doctors for treatment.

Today’s approval of an every six-week dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment,” Baynes said in a statement.


Merck noted that during the pandemic, the company is committed to ensuring its medications reach its patients.

On Tuesday, Merck said the latest regulatory win was made under accelerated approval based on pharmacokinetic data revealed in some ongoing trials. In fact, this week at the virtual American Association for Cancer Research (AACR) Annual Meeting, Merck revealed interim data from Cohort B of KEYNOTE-555, a Phase I trial evaluating a 400 mg every six-week dosing regimen of Keytruda that demonstrated efficacy and safety comparable to findings from previous melanoma trials evaluating the anti-PD-1 drug as a monotherapy. In its announcement, Merck said continued approval for the 400 mg dosing every six weeks could be contingent upon verification and description of clinical benefit in the confirmatory trials. This new dosage option will be available in addition to the current dose of 200 mg every three weeks.

Keytruda is expected to become the world’s top-selling drug over the next few years. The checkpoint inhibitor has been approved for use in various indications more than 20 times by the FDA and is on track for additional approvals, such as in breast cancer. In January, Keytruda posted positive results in the pivotal Phase III KEYNOTE-355 trial in combinations with chemotherapy in patients with metastatic triple-negative breast cancer whose tumors expressed PD-L1. The trial met one of its dual primary endpoints, progression-free survival.

In August, BioSpace took a deep dive into Keytruda and the impact it has had on treating multiple types of cancer, including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck cancer, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel Cell Carcinoma and renal cell carcinoma.

Back To News