FDA Grants Accelerated Approval to GSK’s Jemperli for Rectal Cancer
The FDA approved Jemperli for adults with MSI-H/dMMR stage II/III locally advanced rectal cancer, based on phase II AZUR-1 data. The review continues under Project Orbis.
GSK said the FDA granted accelerated approval to Jemperli (dostarlimab-gxly) as the first immunotherapy for adults with MSI-H/dMMR stage II/III locally advanced rectal cancer. The approval is supported by phase II AZUR-1 data, while reviews continue under Project Orbis.