FDA Grants Accelerated Approval to Jemperli in Locally Advanced Rectal Cancer
GSK sits 16% above its 52-week low of $42.845.
Summary
The FDA granted accelerated approval to Jemperli (dostarlimab) as the first and only immunotherapy for stage II/III dMMR/MSI-H locally advanced rectal cancer, letting eligible patients skip chemo, radiation and surgery. The label rests on the AZUR-1 Phase II trial: of 154 patients, nearly 75% avoided surgery, chemotherapy and radiotherapy entirely, with 68% showing a complete clinical response at 12 months by investigator assessment and 47% by independent central review. This follows the August 24 6-K disclosing FDA priority review with a February PDUFA date, and the approval lands ahead of that date. The addressable group is small — roughly 3% to 10% of rectal cancer patients carry the dMMR/MSI-H biomarker — so near-term revenue is modest, but it is a high-profile label expansion that strengthens the oncology franchise alongside the recent Jideytro NSCLC approval. Full interim AZUR-1 data are slated for presentation at the ESMO Congress in October 2026.
At the time of this announcement, GSK was trading at $49.63 on NYSE in the Life Sciences sector, with a market capitalization of approximately $99.5B. The 52-week trading range was $42.85 to $61.70. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Benzinga.