FDA grants accelerated approval for GSK’s Jemperli in MSI‑H/dMMR locally advanced rectal cancer
On 19 Oct 2026 the U.S. Food and Drug Administration gave accelerated approval to GSK’s anti‑PD‑1 therapy Jemperli (dostarlimab‑gxly) for adults with stage II‑III MSI‑H/dMMR locally advanced rectal cancer. The decision relied on the single‑arm AZUR‑1 trial, which showed a 47 % sustained clinical complete response at 12 months by independent central review and a 68 % response rate by the investigators. GSK said the drug could let eligible patients avoid chemotherapy, radiation and surgery, and the company will present full data at the ESMO Congress in October 2026.
Why it matters
The approval adds a new indication for Jemperli, expanding GSK’s oncology portfolio and opening a market that represents 5‑10 % of rectal cancers, which could boost future oncology revenue (the company noted the market potential in its release). AnaptysBio, GSK’s partner on Jemperli, may see increased royalty payments from the broader patient base, as highlighted in its investor note.
Key facts
- 1The FDA granted accelerated approval to Jemperli on 19 Oct 2026 for stage II‑III MSI‑H/dMMR locally advanced rectal cancer. us.gsk.com
- 2In the AZUR‑1 trial, 47 % of independent central‑review‑evaluable patients achieved a sustained clinical complete response at 12 months. oncnursingnews.com
- 3Investigator assessment reported a 68 % clinical complete response rate at 12 months. us.gsk.com
- 4An exploratory analysis found that 76 % of evaluable patients had no detectable cancer after one year or more of follow‑up. us.gsk.com
- 5Serious adverse reactions occurred in 20 % of patients; the most common side effects were fatigue (32 %), rash (22 %), diarrhea (18 %) and pruritus (17 %). oncnursingnews.com
- 6The FDA’s review used the Real‑Time Oncology Review program and Project Orbis, involving health authorities in Canada, Israel, Switzerland and the United Kingdom. oncnursingnews.com
Summary written by AlphAI AI Desk from 16 of 16 sources. Not investment advice. Figures are as stated by the linked sources.