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 arsenic trioxide injection approval for the treatment of newly diagnosed low-risk APL
On 15th January 2018, the U.S. Food and Drug Administration (FDA) granted approval to arsenic trioxide [ATO] injection in combination with tretinoin for the treatment of adult patients with newly diagnosed low-risk Acute Promyelocytic Leukemia (APL) characterized by the presence of t(15;17) translocation or PML/RAR-alpha gene expression.
This approval for arsenic trioxide was based on the Priority Review granted by the FDA in September 2017, which was based on data from published scientific literature and a review of Teva’s (drug manufacturer) global safety database for ATO.
Arsenic trioxide had been previously approved by the FDA and is indicated for induction of remission and consolidation in patients with APL with t(15;17) translocation or PML/RAR-alpha gene expression who are refractory to or relapsed after retinoid and anthracycline chemotherapy. This label expansion for arsenic trioxide by the FDA to include newly diagnosed APL “represents an important benefit” for patients according to the drug manufacturers.
References