FDA/CDC

FDA approves pembrolizumab for cervical cancer


 

The Food and Drug Administration has approved pembrolizumab (Keytruda) for a new indication: treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1, as determined by an FDA approved test.

“This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” the FDA said in updated labeling.

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Merck’s checkpoint inhibitor, already approved for skin, lung, and gastric cancers, as well as other cancers, won approval for it’s new indication based on 77 patients with tumor programmed cell death ligand 1 combined positive scores of at least 1; almost all had squamous cell cervical carcinoma, but a few had adenocarcinoma or mixed histology, according to labeling.

Two patients (2.6%) had a complete response, and nine (11.7%) had a partial response. Of these 11 patients, 10 had response durations of 6 months or longer. Patients were treated with 200 mg every 3 weeks until unacceptable toxicity or documented disease progression. Over a third had serious adverse reactions, most frequently anemia, fistula, hemorrhage, and infection.

“Keytruda is now the first anti-PD-1 [anti–programmed cell death 1] therapy approved for the treatment of advanced cervical cancer, providing an important new second-line option for certain patients with this disease,” Roy Baynes, MD, a Merck executive, said in a company press release.

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