Jemperli (dostarlimab) Approved in the U.S. as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer
Key Highlights
- ➤Jemperli wins FDA approval as first immunotherapy for stage II/III MSI-H/dMMR rectal cancer
- ➤68% of evaluable patients achieved sustained clinical complete responses at 12 months
- ➤76% of evaluable patients had no evidence of cancer one year or more after treatment
- ➤No disease recurrences reported among responders after median follow-up exceeding two years
- ➤Jemperli monotherapy could help eligible patients avoid chemotherapy, radiation and surgery
* Approval based on AZUR-1 data showing significant proportion of participants with no detectable signs of cancer one year or more after treatment * No disease recurrences reported among responders after median follow up of more than 2 years * Jemperli monotherapy could help eligible patients avoid chemotherapy, radiation and surgery * GSK to present full data from the AZUR-1 interim analysis as a late-breaking abstract at ESMO Congress 2026 in Madrid, Spain on October 25, 2026 SAN DIEGO, Oct. 19, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with Tesaro, a GSK company, and Quimilza (imsidolimab) with Vanda, today announced that GSK has received U.S. Food and Drug Administration (FDA) approval for Jemperli (dostarlimab) as the first and only immunotherapy for adults with stage II and III microsatellite instability-high (MSI-H)/ mismatch repair deficient (dMMR) locally advanced rectal cancer.
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