The FDA approved Jemperli in conjunction with chemotherapy for the treatment of patients with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer. This approval was based on interim data from GSK’s Phase 3 RUBY study, which evaluated Jemperli in combination with chemotherapy. The FDA Oncology Center of Excellence Project Orbis Framework was used to examine the application, which was approved ahead of the expected FDA action date. Jemperli’s approval for this new indication offers the first new frontline therapy option for patients with this kind of endometrial cancer in decades. AnaptysBio, which discovered and licensed Jemperli to GSK, will earn milestone payments and royalties from GSK for Jemperli sales. Jemperli’s approval and future success in other ongoing studies might have a significant impact.

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