Ivosidenib FDA approval : Agios blood cancer drug approved for AML
Ivosidenib FDA approval : The US Food and Drug Administration (FDA) has approved Agios Pharmaceuticals’ blood cancer drug TIBSOVO (ivosidenib) for the treatment of acute myeloid leukemia (AML).
The ivosidenib FDA approval is for the treatment of adult patients whose condition is relapsed or refractory and who are prone to isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test.
TIBSOVO or ivosidenib is an oral, targeted inhibitor of the isocitrate dehydrogenase-1 (IDH1) enzyme. The Agios blood cancer drug is now the first and only FDA-approved therapy for R/R AML patients with an IDH1 mutation1.
Ivosidenib FDA approval was driven by the results of a phase 1 single-arm, dose-escalation and expansion trial of adult patients with R/R AML and an IDH1 mutation.
The clinical trial of ivosidenib saw 174 such patients dosed daily with 500mg of the Agios blood cancer drug until disease progression, development of unacceptable toxicity, or going through hematopoietic stem cell transplantation.
Ivosidenib FDA approval – Agios blood cancer drug TIBSOVO (ivosidenib) approved by US FDA for a type of AML. Photo courtesy of Agios Pharmaceuticals, Inc.
TIBSOVO or ivosidenib demonstrated a combined complete remission (CR) and complete remission with partial hematologic improvement (CRh) rate of 32.8% and an 8.2 months CR+CRh median duration.
Hagop M. Kantarjian – professor and chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, commenting on ivosidenib FDA approval, said: “AML patients who relapse or are refractory to available therapies have few, if any, treatment options.
“The clinical study demonstrated that TIBSOVO has the potential to deliver strong, durable responses as a single agent and can help patients achieve and maintain transfusion independence. IDH inhibitors represent a new class of noncytotoxic, targeted therapies for AML patients with IDH mutations.”
Agios Pharmaceuticals said that TIBSOVO was approved simultaneously with the Abbott RealTime IDH1 companion diagnostic test which helps in selecting patients with R/R AML for treatment with the blood cancer drug.
Commenting on ivosidenib FDA approval, David Schenkein, Agios CEO, said: “The FDA approval of TIBSOVO – our first wholly owned drug and the second approved medicine from our research platform in less than a year – is an incredibly exciting milestone for our company and, importantly, for the approximately 6-10% of AML patients with an IDH1 mutation who have been waiting for new treatment options that work radically different than conventional chemotherapy.”
For more pharma regulatory news like ivosidenib FDA approval, keep following PharmaNewsDaily.com.