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The EMA grants actimab-A Orphan Drug Designation for AML

, May 26, 2017 , Expert Opinion

On 24th May 2017, the European Medicines Agency’s  (EMAs) Committee for Orphan Medicinal Products (COMP) granted Orphan Drug Designation for actimab-A for the treatment of patients with newly diagnosed 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 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

Actimab-A is currently being explored in combination with Low Dose cytosine arabinoside (LDAC) in a phase 2 study (NCT02575963) for previously untreated elderly AML patients who are above the age of 60 and are ineligible for standard induction therapy.

References
  1. GlobeNewswire: Actinium Pharmaceuticals Granted Orphan Designation from the European Medicines Agency for Actimab-A. 2017 May 24. https://globenewswire.com/news-release/2017/05/24/995724/0/en/Actinium-Pharmaceuticals-Granted-Orphan-Designation-from-the-European-Medicines-Agency-for-Actimab-A.html [Accessed 2017 May 25].
  2. Hagemann U. B. et al. In Vitro and In Vivo Efficacy of a Novel CD33-Targeted Thorium-227 Conjugate for the Treatment of Acute Myeloid Leukemia. Mol Cancer Ther. 2016 Oct; 15(10): 2422–2431. DOI: 10.1158/1535-7163.MCT-16-0251. Epub 2016 Aug 17.
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