FDA’s Expanded Approval for GSK’s Jemperli Drive Growth Projections

In August 2024, the U.S. Food and Drug Administration (FDA) granted GSK (LSE: GSK) expanded approval for Jemperli (dostarlimab) in combination with chemotherapy to treat adult patients with primary advanced or recurrent endometrial cancer. The supplemental biologics license application (sBLA) for this use received priority review in April and was approved ahead of the Prescription Drug User Fee Act deadline. Prior to the expanded FDA approval, GSK’s Jemperli (dostarlimab) was initially approved for use in adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer. This approval was granted in April 2021.

Following this expanded approval, analysts expect a significant boost in Jemperli’s revenue for 2024. According to Visible Alpha consensus, U.S. sales of Jemperli are projected to reach £318 million in 2024, up from £108 million in 2023. Globally, Jemperli’s revenue is expected to grow to £392 million in 2024, up from £141 million in 2023, with peak sales estimated to hit £907 million by 2032. However, sales are estimated to decline starting in 2033 as Jemperli’s patent is set to expire on December 31, 2034.