FDA approves MSD’s Keytruda for head and neck cancer treatment
pharmafile | August 8, 2016 | News story | Manufacturing and Production, Research and Development | Cancer, FDA, MSD, keytruda
The US Food and Drug Administration (FDA) has approved MSD’s Keytruda (pembrolizumab) for treatment of recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.
Keytruda is the company’s anti-PD-1 (programmed death receptor-1) and has been approved on the basis of tumour response rate and durability of response taken from the keynote -012 study monitoring the drug’s use in sufferers of the illness. The study found a 16% objective response rate and a 5 % complete response rate, with responses of six months or more observed in 82% of participants.
“Today’s approval represents a meaningful advance for the oncology community, as well as for our head and neck cancer clinical program,” said Dr Roger M Perlmutter, president, Merck Research Laboratories. “Together with prior approvals in the treatment of other tumour types, today’s action by the FDA underscores our tireless commitment to addressing the unmet needs of patients suffering from a broad range of cancers.”
Dr Tanguy Seiwert, associate director of the Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago added: “Head and neck cancer is a complex disease that historically has been associated with high recurrence rates and poor long-term outcomes, highlighting the critical need for new treatment options. The approval of Keytruda for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma is an important step forward in treating this disease.”
Matt Fellows
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