Rigel’s R289 Gains FDA Fast Track For Fighting Lower-Risk MDS
Rigel's R289 earns FDA Fast Track for lower-risk MDS, aiming to address unmet needs in transfusion-dependent patients with limited options.
Breaking News
Dec 03, 2024
Simantini Singh Deo

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a biotechnology company specialising in haematologic disorders and cancer, announced that the FDA has granted Fast Track designation to R289 for treating transfusion-dependent lower-risk myelodysplastic syndrome (LR-MDS) in patients who have received prior treatments. R289, a highly potent dual IRAK1/IRAK4 inhibitor, is currently under evaluation in a Phase 1b study assessing its safety, tolerability, pharmacokinetics, and early effectiveness in LR-MDS patients who have relapsed or are refractory to earlier therapies.
Raul Rodriguez, Rigel's president and CEO, stated, “We are pleased that R289 has been granted Fast Track designation, which underscores the significant unmet need for patients with transfusion dependent lower-risk MDS. By targeting inflammatory signalling, we believe that R289 has the potential to meaningfully improve the lives of those living with this disease."
The Fast Track program aims to accelerate the development and review of drugs targeting serious conditions with unmet medical needs. Drugs granted this designation gain opportunities for enhanced collaboration with the FDA throughout their development. Additionally, they may qualify for Accelerated Approval and Priority Review, provided they meet the necessary criteria.
Lisa Rojkjaer, M.D., Rigel's chief medical officer, said in a statement, "Lower-risk MDS affects a primarily elderly patient population that faces progressive cytopenias, particularly anemia, and treatment options for transfusion-dependent patients are limited. This designation is based on initial data from the ongoing Phase 1b study and highlights the potential of R289 to be a new therapeutic option for these patients. We look forward to working closely with the FDA to advance the clinical development of R289.”