Merck & Co.'s Keytruda gains accelerated FDA approval for advanced cervical cancer

Merck & Co. announced that the FDA approved Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumours express PD-L1. "Keytruda is now the first anti-PD-1 therapy approved for the treatment of advanced cervical cancer," remarked Roy Baynes, chief medical officer at Merck Research Laboratories, adding "this approval also marks the first indication for Keytruda in a gynaecologic cancer."

The company noted that the accelerated approval for Keytruda in cervical cancer is based on tumour response rate and durability of response data from a single cohort of the KEYNOTE-158 study. Results showed that for the 77 patients whose tumours expressed PD-L1, the objective response rate was 14.3 percent, with a complete response rate of 2.6 percent and partial response rate of 11.7 percent. Merck noted that among the 11 patients that benefited from treatment with Keytruda, the median duration of response has not yet reached, while 91 percent experienced a duration of response of six months or longer.

The FDA accepted Merck's filing for Keytruda in advanced cervical cancer in March, granting the submission priority review with a target action date of June 28.

Keytruda is currently approved across a number of tumour types, including melanoma, non-small-cell lung cancer, head and neck Cancer, classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer and certain patients with microsatellite instability-high cancer. Last month, Merck reported that first-quarter sales of the product reached $1.5 billion, up from $584 million in the prior-year period.

For related analysis, see ViewPoints: Keytruda locks the door on competition (and they know it).

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