FDA Grants Accelerated Approval to GSK's Dostarlimab for Stage II-III MSI-H/dMMR Locally Advanced Rectal Cancer

The FDA has granted accelerated approval to GSK's PD-1 inhibitor dostarlimab (Jemperli) as monotherapy for adult patients with stage II or III MSI-H/dMMR locally advanced rectal cancer. In China, the drug is in phase III trials for colon cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer, and is not yet approved.