Jemperli (dostarlimab-gxly) is a GSK plc program in adults with Stage II/III locally advanced rectal cancer that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test (accelerated approval). The FDA approved it on Oct 19, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: adults with Stage II/III locally advanced rectal cancer that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test (accelerated approval) (approved Oct 19, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: GSK plc (GSK). Approval record: Supplemental BLA under the accelerated approval pathway, Priority Review, with a Commissioner's National Priority Voucher; Fast Track and Breakthrough Therapy designations. AZUR-1 (NCT05723562): single-arm, open-label, 154 previously untreated patients, dostarlimab 500 mg IV every 3 weeks for nine cycles. Per the FDA, sustained clinical complete response at 12 months (cCR12) per independent central review was 47% (95% CI 27 to 56) in 116 evaluable patients and 68% (95% CI 60 to 76) by investigator in 144; ORR per ICR 79%; with a median follow-up of 26.3 months, no patient with cCR12, cCR or near CR had progressed. Continued approval may be contingent on a confirmatory trial. Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for Jemperli (dostarlimab-gxly); 1 FDA decision is on record below.
On Oct 19, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Jemperli (dostarlimab-gxly) is FDA-approved for adults with Stage II/III locally advanced rectal cancer that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test (accelerated approval) (approved Oct 19, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
GSK plc (GSK).
Yes. The FDA approved an application for Jemperli (dostarlimab-gxly) on Oct 19, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.