Benzinga | Apr 22, 2021 02:13PM EDT

GlaxoSmithKline's Immunotherapy For Endometrial Cancer Wins FDA Approval

* The FDA has granted accelerated approval to GlaxoSmithKline plc's (NYSE: GSK) Jemperli (dostarlimab) for endometrial cancer.

* The approval covers patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR.

* Jemperli targets the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). Jemperli helps the body's immune system in its fight against cancer cells by blocking this pathway.

* The safety and efficacy of Jemperli was studied in a single-arm, multi-cohort clinical trial. Of the 71 patients in the Jemperli arm, 42.3% had a complete response (disappearance of tumor) or a partial response (shrinkage of tumor) to treatment with Jemperli. For 93% of responders, the response lasted for six months or more.

* Price Action: GSK shares are down 1.45% at $37.69 in market hours on the last check Thursday.