Merck & Co’s immunotherapy cancer drug to have FDA review

Merck and Co have announced that the US Food and Drug Administration (FDA) has accepted its supplemental biologics licence application (sBLA) for its immunotherapy cancer drug to treat head and neck cancer.

The sBLA is to be reviewed under the FDA’s accelerated approval program, which means it has a target action date of August 9th 2016.

Keytruda is a humanised monoclonal antibody that blocks the PD-1 protein to stop it from affecting healthy cells, which increases the ability of the body's immune system to help detect and fight tumour cells.

The drug was already approved in 2014 as a treatment for melanoma and in October 2015 for non-small-cell lung cancer.

Roger Dansey, senior vice president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said: "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."