GSK to seek FDA approval for Jemperli in high-profile cancer use

GSK's Jemperli (dostarlimab) has met primary endpoints in phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with sustained clinical complete responses at 12 months, paving the way for FDA accelerated approval filing. The indication represents a small but high-profile market where the drug could eliminate need for chemotherapy, radiation and surgery in eligible patients. A PD-1 inhibitor that eliminates surgery for some rectal cancer patients just cleared its biggest regulatory hurdle—and it's a small, orphan-like market where one drug can own the standard of care. If you're building diagnostic or treatment planning software for colorectal cancer, your customer base is about to shrink, but your pricing power just went up.