Merck : FDA Approves KEYTRUDA Combination For Advanced Cervical Cancer Treatment

(RTTNews) - Merck & Co. Inc. (MRK) said that the U.S. Food and Drug Administration has approved KEYTRUDA, the company's anti-PD-1 therapy, in combination with chemoradiotherapy or CRT for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

The approval was based on data from the Phase 3 KEYNOTE-A18 trial, in which KEYTRUDA plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group. This approval marks the third indication for KEYTRUDA in cervical cancer and the 39th indication for KEYTRUDA in the U.S.

In the U.S., KEYTRUDA has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 as determined by an FDA-approved test; and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test.

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