UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its drug Jemperli (dostarlimab). The designation is for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer.
Jemperli’s Background and Licensing History
Jemperli, a programmed-death 1 (PD-1) monoclonal antibody (mAb), was discovered by AnaptysBio, Inc. and was licensed to TESARO, Inc., in a deal that took place in March 2014. Under the terms of that agreement, GSK is responsible for the ongoing research, development, commercialization, and manufacturing of both Jemperli and cobolimab (GSK4069889), a TIM-3 antagonist.
FDA Approval and Clinical Trial Results
Jemperli gained FDA approval in July 2023 for use in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. In June 2024, GSK revealed results from a trial for Jemperli (dostarlimab-gxly) that demonstrated an unprecedented 100% clinical complete response (cCR) in patients with locally advanced rectal cancer.-Fineline Info & Tech
