A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine) (CGX-635) in the Treatment of Patients With Chronic Myeloid Leukemia. (CML) With the T315I BCR-ABL Gene Mutation.
Latest Information Update: 16 Nov 2021
At a glance
- Drugs Omacetaxine mepesuccinate (Primary)
- Indications Chronic myeloid leukaemia
- Focus Adverse reactions; Therapeutic Use
- Sponsors ChemGenex Pharmaceuticals; Teva Branded Pharmaceutical Products R&D; Teva Pharmaceutical Industries
- 02 Jun 2014 Duration of maintenance therapy changed from up to 2 years to 3 years.
- 13 Feb 2014 The US FDA has approved omacetaxine mepesuccinate for injection based on results from this and another pivotal phase II trial according to a Teva Pharmaceuticals Industries media release.
- 10 Dec 2013 Pooled analysis of a subgroup of patients resistant/intolerant to dasatinib or nilotinib presented at the 55th Annual Meeting and Exposition of the American Society of Hematology.