FDA accepts Keytruda head and neck cancer filing

Merck’s PD-1 inhibitor Keytruda (pembrolizumab) has been accepted for priority review by the FDA in another new setting, head and neck cancer.

The filing is for Keytruda as a single therapy administered every three weeks at a 200mg dose in cases of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-based chemotherapy.

With FDA acceptance, the submission will now be reviewed under the FDA’s Accelerated Approval programme with a target date of 9 August.

The FDA filing puts Keytruda one step ahead of its big rival in the area, Bristol Myers-Squibb’s PD-1 inhibitor Opdivo (nivolumab). The announcement means Keytruda should be the first to gain a licence in HNSCC.  BMS has accelerated its development of Opdivo in the tumour type, skipping mid-stage trials and moving straight to phase 3 studies, but is yet to file in the indication.

Both drugs gained their first approvals in advanced melanoma, and are both now also approved against non-small cell lung cancer (NSCLC). Opdivo became the first in the class to gain approval in renal cell carcinoma in November, a pattern of rivalry which is set to continue across more tumour types over the coming years.

One example of this is in advanced colorectal cancer, where the FDA granted Keytruda a Breakthrough therapy designation in November.

Commnenting on the HNSCC filing, Senior vice president and therapeutic area head, oncology late-stage development for Merck, Roger Dansey, said: “We are encouraged by the data emerging from our programme in this type of cancer, and welcome today’s news as this is an important step toward making Keytruda available to these patients.”

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