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FDA accepts Merck’s sBLA for Keytruda six-week dosing schedule for melanoma and multiple other indications

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Merck announced that the US Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, Merck’s anti-PD-1 therapy, to include an every-six-weeks (Q6W) dosing schedule option.

Merck is seeking FDA approval of a 400 mg Q6W dose infused over 30 minutes for KEYTRUDA indications in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma.

 If approved by the FDA, the Q6W dose would be available for use in adults in addition to the currently approved dose of KEYTRUDA 200 mg every three weeks (Q3W) infused over 30 minutes. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Feb. 18, 2020.

“We are committed to improving cancer care, which includes identifying ways to ensure patients have a flexible dosing option that may reduce the amount of time they spend receiving treatment,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

“If approved, the six-week dosing schedule will provide physicians and patients with greater flexibility in their treatment plans across a variety of cancer types, including melanoma where KEYTRUDA is indicated in both the adjuvant and metastatic settings. We look forward to working with the FDA to file additional KEYTRUDA dosing sBLAs later this year.”

In the EU, 400 mg Q6W dosing for KEYTRUDA monotherapy was approved by the European Commission on March 28, 2019.

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Source: Company Press Release