Synribo omacetaxine mepesuccinate regulatory update

FDA approved an updated label for Synribo omacetaxine mepesuccinate from Teva to allow home administration of the drug to treat chronic or accelerated phase chronic myelogenous leukemia (CML) in adults with resistance and/or intolerance to >=2 tyrosine kinase inhibitors (TKIs). Previously, patients had to receive subcutaneous injections of Synribo at their doctor's office twice daily for 2 weeks. The agency also approved a medication guide and instructions for use at home. Teva is finalizing a specialty pharmacy support program to facilitate home administration and plans to launch the program this quarter. ...