US regulators have agreed to undertake a speedy review of Merck & Co’s application to market immunotherapy Keytruda for the treatment of certain patients with head and neck cancer, it third potential indication in the country.
The company is targeting the drug towards patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
“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 (pembrolizumab) available to these patients,” said Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
The US Food and Drug Administration has set an action date for Keytruda - an anti-PD-1 therapy dosed as a single agent intravenously every three weeks - of August 9.
Keytruda is a humanised monoclonal antibody that boosts the ability of the body’s immune system to help detect and fight tumour cells. The drug has already racked up approvals in melanoma and lung cancer in the US.