Teva Pharmaceuticals announced that the FDA has approved Synribo (omacetaxine mepesuccinate) for Injection to treat adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
The approval is based on an analysis of combined data subsets from two Phase 2, open-label, multicenter studies. The pooled analysis included patients who had received ≥2 approved TKIs and, at a minimum, had evidence of resistance or intolerance to dasatinib (Sprycel; Bristol-Myers Squibb) and/or nilotinib (Tasigna; Novartis). A total of 47% of CP patients and 63% of AP patients had failed treatment with imatinib (Gleevec; Novartis), dasatinib, and nilotinib. The majority of patients had also received other treatments including hydroxyurea (Hydrea; Bristol-Myers Squibb), interferon, and cytarabine (Bedford Laboratories).
- For CP patients, 18% (14/76) achieved a major cytogenetic response (MCyR) with a mean time to MCyR onset of 3.5 months. The median duration of MCyR for these patients was 12.5 months (Kaplan-Meier estimate).
- For AP Patients, 14% (5/35) achieved a major hematologic response (MaHR) with a mean time to response onset of 2.3 months. The median duration of MaHR for these patients was 4.7 months (Kaplan-Meier estimate).
The mechanism of action of Synribo has not been fully elucidated but includes inhibition of protein synthesis. It acts independently of direct Bcr-Abl binding to reduce protein levels of both the Bcr-Abl oncoprotein and Mcl-1 which inhibits apoptosis, in vitro.
Synribo will be available for prescribing shortly.
For more information call (888) TEVA-USA or visit www.tevausa.com.