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Merck says US FDA to review its Keytruda for head & neck cancer

Published on 14/04/16 at 09:49am

The US Food and Drug Administration has accepted Merck & Co’s (NYSE: MRK) supplemental biologics license application (sBLA) for its immunotherapy cancer drug to treat head and neck cancer, the company said.

The US regulators granted Keytruda (pembrolizumab) priority review with a target action, date of August 9. The sBLA will be reviewed under the FDA’s accelerated approval program.

Keytruda is a humanized monoclonal antibody that can increase the ability of the body's immune system to help detect and fight tumor cells. Keytruda blocks a protein called programmed death receptor 1, or PD-1, to stop it from affecting healthy cells.

Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, 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. 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.”

Keytruda belongs to the immunotherapy class of drugs that utilise the immune system to fight cancerous tumours. The drug was approved in 2014 as treatment for melanoma and in October 2015 for non-small-cell lung cancer.

Anjali Shukla

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