Jemperli (dostarlimab-gxly) was approved by the FDA on October 19, 2026 for dMMR/MSI-H locally advanced rectal cancer.
Verified against: FDA action day October 19, 2026 (FDA accelerated approval notification) · Announcement October 19, 2026 (GSK press release) · Goal month February 2027, no day stated (GSK press release).
The FDA granted accelerated approval to Jemperli as the first immunotherapy for adults with mismatch repair deficient or microsatellite instability high locally advanced rectal cancer, on the single-arm AZUR-1 study. GSK says eligible patients may be able to avoid chemotherapy, radiation and surgery; continued approval may depend on a confirmatory trial.
The FDA's notification states that on October 19, 2026 it granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with Stage II/III locally advanced rectal cancer that is MSI-H or dMMR (FDA, October 19, 2026). GSK announced the approval the same day from Philadelphia (GSK's announcement). The goal date was stated by GSK as February 2027 when the sBLA was accepted for priority review (GSK, August 24, 2026); because that goal is a month rather than a day, pdufa.bio publishes no early or late margin, although GSK's release says the approval came ahead of the PDUFA date under Priority Review and a Commissioner's National Priority Voucher. The FDA's letter for BLA 761174 had not been posted on Drugs@FDA when this page was published. Per the FDA, AZUR-1 (NCT05723562) was a single-arm, open-label study of 154 previously untreated patients given dostarlimab 500 mg every three weeks for nine cycles; sustained clinical complete response at 12 months was 47% (95% CI 27 to 56) by independent central review in 116 evaluable patients and 68% (95% CI 60 to 76) by investigator assessment in 144, overall response by central review was 79%, and with a median follow-up of 26.3 months no patient with a complete or near-complete response had progressed. Jemperli holds Fast Track and Breakthrough Therapy designations for this indication.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA accelerated approval notification, October 19, 2026
FDA record of the action: the FDA approved on October 19, 2026, per FDA accelerated approval notification (sBLA, BLA 761174; letter not yet on Drugs@FDA) (FDA notice). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Jemperli (dostarlimab-gxly) on October 19, 2026, per the FDA's own record. The primary source is linked on this page.
Jemperli (dostarlimab-gxly) is a GSK plc (GSK) program. The FDA decision came on October 19, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), GSK moved -9.6%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
Yes. The FDA granted accelerated approval on October 19, 2026 to dostarlimab-gxly (Jemperli) for adults with Stage II/III locally advanced rectal cancer that is mismatch repair deficient or microsatellite instability high, per the FDA's own notification. GSK announced it the same day. Continued approval may depend on a confirmatory trial.
The FDA acted on October 19, 2026. GSK's August 24, 2026 release stated the goal date as February 2027, a month rather than a day, so pdufa.bio does not publish an early or late margin for this decision. GSK's release says the approval came ahead of the PDUFA date; the application carried Priority Review and a Commissioner's National Priority Voucher.
Per the FDA, AZUR-1 (NCT05723562) enrolled 154 previously untreated patients who received dostarlimab alone for nine cycles. Sustained clinical complete response at 12 months was 47% by independent central review in 116 evaluable patients and 68% by investigator assessment in 144; overall response by central review was 79%. With a median follow-up of 26.3 months, no patient with a complete or near-complete response had progressed.