TRANSLATE

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

Investigational new drug application for VOR33 cleared by the FDA

By Claire Baker

Share:

Jan 18, 2021


On January 14, 2021, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for VOR33 in patients at risk of relapse with acute myeloid leukemia (AML).

VOR33

The engineered hematopoietic stem cell (eHSC) therapy, VOR33, involves reconstitution with cells lacking CD33. The rationale behind this is to allow for subsequent treatment with the CD33-directed antibodydrug conjugate, gemtuzumab ozogamicin, while limiting myelosuppression and the resulting toxicities.

The clearance of the IND application allows the initiation of a phase I/IIa trial, which will evaluate the safety and feasibility of VOR33 in patients with CD33+ AML who will likely relapse. Investigators hope to determine whether VOR33 can engraft sufficiently. Following successful engraftment, enrolled patients will be offered treatment with gemtuzumab ozogamicin, with the hope to improve leukemia-free survival.

HSC with VOR33 may be an effective approach in achieving hematopoietic reconstitution that is resistant to CD33-targeted therapies, thereby improving posttransplant outcomes in patients with AML.

References

Please indicate your level of agreement with the following statements:

The content was clear and easy to understand

The content addressed the learning objectives

The content was relevant to my practice

I will change my clinical practice as a result of this content