FDA approves 2 new indications for Merck's Keytruda

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FDA approves 2 new indications for Merck's Keytruda

By Sandra Levy - 06/11/2019
Merck has received the Food and Drug Administration’s clearance for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy in patients whose tumors express PD-L1 or in combination with platinum and fluorouracil, a commonly used chemotherapy regimen, for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.

“This approval is a very exciting milestone in the treatment of head and neck cancer and has the potential to transform the way we treat patients with this debilitating disease by offering important new therapeutic options,” professor of medicine, Yale School of Medicine and co-director, Development Therapeutics Research Program, Yale Cancer Center, Barbara Burtness said. “Metastatic or recurrent head and neck cancer has been an area of significant unmet need, so it is encouraging to have immunotherapy regimens available for patients in the first-line setting.”

“Head and neck squamous cell carcinoma has historically presented many challenges to physicians and patients, including limited treatment options and physical and functional issues caused by the disease and its treatment,” Merck Research Laboratories vice president, clinical research, Jonathan Cheng said, adding, "This approval is an important advance in the management of this devastating cancer."

Keytruda was initially approved for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy in 2016 under the FDA’s accelerated approval process.

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