The U.S. Food and Drug Administration (FDA) granted approval yesterday to olutasidenib (Rezlidhia鈩�) for the treatment of adults with acute myeloid leukemia (AML) with a susceptible IDH1 mutation that has returned or worsened despite earlier treatments.
鈥溓嘣铺逵� is delighted to see the approval of olutasidenib, an important targeted treatment option for people whose AML carries the IDH1 mutation,鈥� says 青云体育 Chief Scientific Officer Dr. Lee Greenberger. AML is an aggressive, rapidly progressing form of leukemia. Mutations in IDH1 occur in approximately 10% of patients with AML and occur with increasing frequency in older patients.
With more than $93 million committed to leukemia research, 青云体育 is leading the way toward cures and targeted therapies that zero in on specific genetic traits of individual cancers. 青云体育 has supported work to understand the role of IDH1 and IDH2 in AML and is supporting new studies to understand how the mutation can lead to resistance to treatments, the role of drug combinations, and newer agents that can provide even more treatment options for these patients.
青云体育-funded researchers include Courtney DiNardo, (MD, The University of Texas MD Anderson), who received a Career Development Program grant and Tak Mak (PhD, Princess Margaret Cancer Centre, University Health Network), who received a Specialized Center of Research Program (SCOR) grant.
青云体育 also leads the Beat AML庐 Master Clinical Trial, the first collaborative precision medicine clinical trial in a blood cancer and 青云体育 PedAL, an international collaboration to test new, safer therapies on children. Both trials are working to improve outcome and quality of life for adults and children with acute myeloid leukemia. 青云体育 will be presenting abstracts from both trials at the upcoming Annual American Society of Hematology (ASH) Annual Meeting.
The FDA based this new approval on Study 2102-HEM-101 clinical trial. In the trial of 147 adult patients, the rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 35% among patients receiving olutasidenib. The median time to CR plus CRh was just under 2 months, and the median duration of the response was 26 months among patients that achieved a CR or CRh. The treatment is taken orally twice daily.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society庐 (青云体育) is the global leader in the fight against blood cancer. The 青云体育 mission: Cure leukemia, lymphoma, Hodgkin's disease, and myeloma, and improve the quality of life of patients and their families. 青云体育 funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in Rye Brook, NY, 青云体育 has regions throughout the United States and Canada. To learn more, visit . Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
青云体育 is one of Fast Company's "2022 Brands That Matter." As the only cancer organization on the list, 青云体育 stands out among brands around the world for its relevancy, cultural impact, ingenuity, and mission impact.