Servier Pharmaceuticals anncounces that a new treatment combination utilizing their drug Tibsovo (ivosidenib) was FDA approved this past week. According to the U.S. Food and Drug Administration (FDA), Tibsovo (ivosidenib tablets) can now be used in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML (and for those who do not qualify for intensive chemotherapy as well as those patients who are 75 years or older and patients with relapsed or refractory AML).
Info About This Combination:
- IDH1 (isocitrate dehydrogenase) is one of the more common mutations seen among AML patients
- Oral ivosidenib (500 mg) is given once daily
- Subcutaneous or intravenous azacitidine is given for 7 days in 28-day cycles
“Tibsovo is the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML.” For Servier, a leader in oncology pioneering the IDH inhibition, this is a significant and new therapeutic option for all those in the AML community.
The approval of Tibsovo was based on the global, AGILE Phase 3 study, which was designed to evaluate the efficiency and safety of Tibsovo in combination with azacitidine compared with placebo in combination with azacitidine. This study showed greater event free survival (EFS) and overall survival (OS). Tibsovo plus azacitidine treatment showed an overall survival of 24 months compared to 7.9 months when a placebo was used.
Previously, newly diagnosed AML patients that did not qualify for intensive chemotherapy had very few treatment options. The new approval of Tibsovo in combination with azacitidine represents a major advancement for patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
“In an effort to support the patient communities it serves, Servier Pharmaceuticals recently introduced ServierONE Patient Support Services, a program that offers one-on-one support to help patients who are prescribed Tibsovo or other Servier products navigate their cancer journey. Eligible patients will have access to financial assistance, emotional support and other resources. More information can be found at www.servierone.com.”
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Lisa Foster is a mom of 3 daughters, a puzzle lover, writer and HealthTree advocate. She believes in the mission of the foundation and the team that builds it forward. She calls Houston, Texas home.