Teva’s CML drug approved
pharmafile | October 29, 2012 | News story | Research and Development, Sales and Marketing | FDA, Synribo, Teva
Teva’s new treatment for chronic myeloid leukemia Synribo has been approved by the FDA.
Synribo (omacetaxine mepesuccinate) is an injectable treatment for 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 indication is based upon response rate, and Synribo currently has no trial data showing it improves disease-related symptoms or increased survival.
The drug was approved by the FDA on the basis of likely future data showing it benefits patients. It offers a new option for CML patients who have failed on two or more TKIs and have had limited options.
“While the CML treatment landscape has seen advancements with available TKI treatments, there are still cases where patients may not be able to continue using TKIs due to issues such as resistance, intolerance, suboptimal response, and disease progression,” said Jorge Cortes, deputy chair and professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center.
“With Synribo, physicians will now have access to another option, offering potential hope to patients who experience treatment failure.”
The drug received an accelerated approval that allows the FDA to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
The programme is designed to provide patients with earlier access to promising new drugs. Full approval is expected following submission of more mature data from pivotal analysis.
“Teva Pharmaceuticals is pleased to bring SYNRIBO to the market for patients who need additional treatment options when others have failed,” said Michael Hayden, president of Global R&D and chief scientific officer of Teva.
“Synnribo joins Treanda and Trisenox as important haematologic treatment options in the Teva Oncology portfolio.”
The approval is based on an analysis of combined data subsets from two Phase II, open-label, multicentre studies. The pooled analysis included patients who had received tqo or more approved TKIs and, at a minimum, had evidence of resistance or intolerance to dasatinib and/or nilotinib.
47% of CP patients and 63% of AP patients had failed treatment with imatinib, dasatinib, and nilotinib. The majority of patients had also received other treatments including hydroxyurea, interferon, and cytarabine.
• 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).
• Most common adverse reactions (frequency ≥20%) in chronic and accelerated phase patients: thrombocytopenia, anemia, neutropenia, diarrhoea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia.
Administered subcutaneously, Synribo will be dosed twice-daily for 14 consecutive days of a 28-day cycle at treatment induction, and twice-daily for seven consecutive days of a 28-day cycle during maintenance therapy once a response is achieved.
Andrew McConaghie
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