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FDA Approves GSK's BLA For Jemperli In Treatment Of Endometrial Cancer

GlaxoSmithKline plc (GSK) Thursday said US Food and Drug Administration has approved Jemperli for endometrial cancer, based on the company's Biologics License Application.

Jemperli is indicated for the treatment of adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company said.

About 25% of patients with with endometrial cancer have dMMR tumors. A clinical trial with 71 patients found that Jemperli showed an overall response rate in 42% of the patients.

GSK is also studying Jemperli for endometrial cancer in earlier treatment lines and in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer as we work to expand our oncology pipeline and reinforce our portfolio of cancer treatments.

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