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Rigel Pharmaceuticals Reports Publication In The Journal Of Hematology & Oncology; 5-Year Data Showing Durable Efficacy And Manageable Safety For REZLIDHIA In R/R mIDH1 AML

Benzinga·11/17/2025 13:15:23
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  • Olutasidenib continued to demonstrate durable efficacy and a manageable safety profile in a broad range of patients with R/R mIDH1 AML, including those previously treated with venetoclax-based regimens
  • Rigel advances its strategic collaborations to further evaluate olutasidenib with the activation of a fifth study with MD Anderson and enrollment of the first patient in the CONNECT TarGeT-D study

SOUTH SAN FRANCISCO, Calif., Nov. 17, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced a peer-reviewed publication in the Journal of Hematology & Oncology of the final five-year data from the pivotal cohort of the Phase 2 registrational trial evaluating REZLIDHIA® (olutasidenib) for the treatment of patients with relapsed or refractory (R/R) mutant isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML). REZLIDHIA is a potent, selective, oral, small-molecule inhibitor of mIDH11 that is approved for the treatment of R/R mIDH1 AML.

The publication reports the final follow-up analysis of the registrational Phase 2 trial, with an additional two years of efficacy and safety data. These five-year data further support the durable responses and manageable safety profile observed with olutasidenib in patients with R/R mIDH1 AML, including those R/R to prior venetoclax. The safety profile remained consistent with what was previously reported, with no new safety signals identified.