The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View aml content recommended for you
FDA grants Tibsovo (ivosidenib) approval for the treatment of patients with relapsed/refractory acute myeloid leukemia with IDH1 mutation
On 20th July 2018, the U.S. Food and Drug Administration (FDA) granted approval to Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an Isocitrate Dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.1 The approval comes after the priority review designation granted to Tibsovo in February 2018, which was reported here.
This approval for Tibsovo, a first in class, oral, selective inhibitor of mutations in IDH1, was based on data from the phase I dose-escalation and expansion AG-120-C-001 study (NCT02074839), which is assessing the safety and efficacy of ivosidenib monotherapy in patients with IDH1 mutated (mIDH1) advanced hematologic malignancies. The results from the cohort of patients with R/R AML were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting by Daniel Pollyea from the University of Colorado School of Medicine, Aurora, CO and reported by the AML Global Portal here.
In this study, Tibsovo (500 mg daily dose) was evaluated in 174 patients (median age = 67 years) with mIDH1 R/R AML. Complete Response (CR) or CR with partial hematologic recovery (CRh) rate was 32.8% with a median duration of 8.2 months and a median overall survival (OS) of 9.0 months. Median OS in responders was 18.8 months. 2
In an interview with the AGP, Courtney DiNardo from the MD Anderson Cancer Center, Houston, TX, commented on the findings of this study in which she stated that ivosidenib monotherapy was “well tolerated” in patients with mutated IDH1 AML. Additionally, in R/R AML patients with unmet medical needs, ivosidenib induced durable responses and improved patient outcomes. She concluded by noting that the findings of this phase I study support the role of ivosidenib as an “effective, oral targeted treatment for patients with mIDH1 AML”.
Tibsovo was approved alongside the Abbott RealTime™ IDH1 companion diagnostic test, which is FDA-approved as an aid in identifying IDH1 mutated AML patients for treatment with Tibsovo.
References