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FDA Approves Pembrolizumab for Relapsed/Refractory PMBCL, Advanced Cervical Cancer
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Officials with the FDA have granted accelerated approval to pembrolizumab (Keytruda, Merck) for 2 new indications, including the treatment of refractory primary mediastinal large B-cell lymphoma (PMBCL), and recurrent metastatic cervical cancer in previously treated patients whose tumors express PD-L1.
Officials with the FDA have granted accelerated approval to pembrolizumab (Keytruda, Merck) for 2 new indications, including the treatment of refractory primary mediastinal large B-cell lymphoma (PMBCL), and recurrent metastatic cervical cancer in previously treated patients whose tumors express PD-L1, according to a press release.
The agency’s approval of pembrolizumab for recurrent metastatic cervical cancer makes it the first anti-PD-1 therapy approved for this patient population, Merck announced in a news release.
For the treatment of PMBCL, pembrolizumab is approved for use in both adult and pediatric patients, and those who have relapsed after 2 or more prior lines of therapy. The approval is based on data from the KEYNOTE-170 trial, which evaluated 53 patients with relapsed or refractory PMBCL. Patients were treated with pembrolizumab 200 mg intravenously every 3 weeks until acceptable toxicity or documented disease progression, or for up to 24 months for patients who did not progress.
According to Merck, pembrolizumab’s indication for recurrent metastatic cervical cancer is based on the KEYNOTE-158 trial, which investigated the efficacy of pembrolizumab in 98 patients with recurrent or metastatic cervical cancer, excluding patients with autoimmune disease or a medical condition that required immunosuppression. Patients were treated with pembrolizumab intravenously at a dose of 200 mg every 3 weeks until acceptable toxicity or documented disease progression.
“Even with the many advances observed across gynecologic cancers, new treatment options have been lacking for previously treated patients with advanced cervical cancer,” Bradley Monk, MD, oncologist with Arizona Oncology, medical director of US Oncology Research Gynecology Program, said in the press release. “This approval of Keytruda in this indication is important news—and as an oncologist, it is exciting to see a much needed option made available to these patients.”
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