Merck Says FDA Accepts Its sBLA For Keytruda And Grants Priority Review

Merck & Co., Inc. MRK said the FDA has accepted its supplemental Biologics License Application (sBLA) for its Keytruda, which is anti-PD-1 therapy. The drug is meant for treating patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. According to the company, the regulator has also granted a priority review on August 9.

Merck said the application sought the FDA approval as a single agent at a dose of 200 mg administered intravenously every three weeks. The company said the review will be done under the FDA's Accelerated Approval Program.

The company's SVP and therapeutic area head, Roger Dansey, said, "Starting in the early days of our development program, we have explored the role of KEYTRUDA for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options."

Dansey commented, "We are encouraged by the data emerging from our program in this type of cancer, and welcome today's news as this is an important step toward making KEYTRUDA available to these patients."

On Tuesday, shares of the company closed with a gain of 0.53 percent.