All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

  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

FDA grants Investigational New Drug clearance for actimab-A in combination with CLAG-M for R/R AML patients

By Cynthia Umukoro

Share:

Mar 13, 2018


On 13th March 2018, the U.S. Food and Drug Administration (FDA) granted Investigational New Drug (IND) application clearance for the phase I trial of actimab-A in combination with cladribine, cytarabine, and filgrastim with mitoxantrone (CLAG-M) for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).1

Actimab-A, an antibody-drug conjugate (ADC), consists of the CD33-targeting monoclonal antibody lintuzumab and the alpha-emitting radioisotope actinium-225. Actimab-A targets CD33 (expressed on a majority of AML cells) via the antibody lintuzumab and delivers powerful actinium-225, which kills the AML cells. Actinium-225 releases high-energy alpha particles as it decays, which kills cancer cells.2

The IND approval allows the investigator’s led phase I study, which is assessing the safety and efficacy (based on response rates, percentage of patients receiving a bone marrow transplant and overall survival) of actimab-A in combination with CLAG-M in up to 18 R/R AML patients to proceed. The trial would be conducted at the Medical College of Wisconsin and would be led by principal investigator Dr. Sameem Abedin in collaboration with Dr. Ehab Atallah.1

References