GSK (GSK) Gains FDA Approval for Jemperli, Boosting Outlook for

GSK's Jemperli (dostarlimab) received accelerated approval from the US FDA for treating rectal cancer, marking the 11th approval under the National Priority Voucher program. The drug is a PD-1-blocking antibody indicated as a single-agent treatment.

GSK's Jemperli (dostarlimab-gxly) received FDA approval for advanced rectal cancer. The accelerated approval is based on AZUR-1 trial data showing 68% of patients achieved sustained clinical complete responses at 12 months. GSK reported no disease recurrences among responders after a median follow-up of over two years. The drug received Fast Track, Breakthrough Therapy, and Priority Review designations.

GSK received FDA accelerated approval for Jemperli to treat MSI-H/dMMR rectal cancer, supported by phase II data. This expands Jemperli's oncology indications, following prior approvals in gynecologic cancers, according to the company.

GSK's Jemperli (dostarlimab-gxly) received FDA approval for treating locally advanced rectal cancer with MSI-H/dMMR biomarkers, based on AZUR-1 trial data showing sustained clinical complete responses. The treatment may help patients avoid chemotherapy, radiation, and surgery. GSK licensed Jemperli from AnaptysBio and TESARO. The approval was expedited under Fast Track, Breakthrough Therapy, and Priority Review designations.

AnaptysBio (ANAB) announced FDA approval for GSK's Jemperli (dostarlimab) to treat locally advanced rectal cancer, based on AZUR-1 trial data. The drug showed significant clinical responses, potentially avoiding chemo, radiation, and surgery. GSK will present full data at ESMO Congress 2026. ANAB manages financial collaborations for Jemperli.

The FDA approved GSK's Jemperli for first-line treatment of MSI-High, dMMR rectal cancer. This expands the drug's approved uses, potentially increasing its market. GSK develops and markets Jemperli.