February 13, 2014
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration(FDA) has granted full approval of SYNRIBO® (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.
SYNRIBO is indicated 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).
“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of SYNRIBO®, we believe healthcare providers can be even more confident in the clinical profile of this important medicine,” said Rob Koremans, M.D., President and CEO, Global Specialty Medicines. “This approval reinforces our ongoing commitment to providing SYNRIBO® to people living with CML who have failed two or more TKI therapies.”
SYNRIBO® is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).
Chronic myeloid leukemia (also called chronic myelogenous leukemia) is one of four main types of leukemia and is a cancer of the blood and bone marrow. In CML, part of the DNA from chromosome 9 breaks off and trades places with chromosome 22 during cell division. This results in the “Philadelphia chromosome,” which is an abnormal chromosome 22 that contains the BCR-ABL hybrid gene. This hybrid gene leads to over-production of the enzyme tyrosine kinase in the bone marrow, which causes too many stem cells to develop into white blood cells (granulocytes or blasts). The American Cancer Society estimates that in 2014, there will be 5,980 new cases of CML diagnosed in the United States, and 810 deaths from the disease. The prevalence of CML has grown significantly since 2001 after the introduction of new treatments. It is estimated that the prevalence of CML in the United States is 26,359, according to the Leukemia & Lymphoma Society.
SYNRIBO®, which was originally granted an accelerated approval by the FDA inOctober 2012, is the first protein synthesis inhibitor for CML. While a detailed understanding of how SYNRIBO® works has not been fully defined, it has been shown to prevent the production of specific proteins. The proteins affected by SYNRIBO® are known as Bcr-Abl and Mcl-1, as shown in laboratory studies not involving patients. These are examples of some of the proteins that are produced in higher levels by cancerous CML cells and help drive the disease. As a protein synthesis inhibitor, the way SYNRIBO® is believed to work does not directly depend on Bcr-Abl binding.
For Full Prescribing Information, click here.
About the Phase 2 Pivotal Studies (202 and 203)
The original approval of SYNRIBO® was 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 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, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
Find the press release here.