Tibsovo Approved to Treat Acute Myeloid Leukemia
July 20, 2018 – The U.S. FDA has approved Tibsovo® (ivosidenib), manufactured by Agios Pharmaceuticals, to treat adult patients who have relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The IDH1 mutation must be verified by an FDA-approved diagnostic test.
Approximately 6% to 10% of AML patients are affected by the IDH1 mutation, which prevents the normal development of blood cells. According to the National Cancer Institute, an estimated 19,520 individuals in the United States will be diagnosed with AML in 2018 and an estimated 10,670 AML patients will die of the disease in the same year. The cancer begins in the bone marrow and progresses rapidly. Although AML can be treated, relapses are common. A patient’s prognosis is often poor once a relapse has occurred.
In a clinical study, 32.8% of patients with R/R AML and a confirmed IDH1 mutation who received Tibsovo experienced either complete remission (CR) or complete remission with partial hematologic improvement (CRh). The median length of response was 8.2 months. Recommended dosing is 500mg twice daily until treatment intolerance or disease progression. Tibsovo carries a black box warning that it may cause differentiation syndrome, a potentially fatal condition. Patients who exhibit symptoms of differentiation syndrome should be closely monitored.
Agios has launched Tibsovo at an average wholesale price (AWP) of $31,338 per month.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.