US FDA Approves Teva's Chronic Myelogenous Leukemia Drug, Synribo

The U.S. Food and Drug Administration (US FDA) has approved Teva Pharmaceuticals' drug, Synribo (omacetaxine mepesuccinate), for the treatment of chronic or accelerated phase of chronic myelogenous leukemia (CML) in adults. The National Institutes of Health estimates that, in 2012, about 5,430 Americans will be diagnosed with CML, a type of the blood and bone marrow cancer.

Synribo is indicated for patients in whom treatments with at least two other specific anti-cancer drugs have failed. Synribo received approval under FDA's accelerated approval program. This fast-track approval provides patients with earlier access to promising new drugs while the pharmaceutical company conducts further clinical trials to confirm the efficacy and safety of the drug.

Synribo is an under-the-skin injectable drug, which inhibits certain proteins that promote the development of cancerous cells. It is given twice a day for 14 consecutive days over the course of a 28-day cycle until the normalization of white blood cell counts. Synribo is then administered twice daily for 7 consecutive days over a 28-day cycle.

"Today's approval provides a new treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML," said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research.

Synribo is the second CML drug approved by FDA in the last few months after the approval of Pfizer Inc's Bosulif for the treatment of refractory or relapsed CML. Synribo also received FDA's orphan-product designation as it's intended to treat a rare disease. Orphan drugs are used to treat conditions or rare diseases that affect fewer than 200,000 people.

FDA's evaluation of Synribo was based on the analysis of two Phase 2 clinical trials enrolling patients with CML in chronic phase and in accelerated phase. Results of chronic phase CML showed a reduction in cancer cells within an average time of 3.5 months in 14 out of 76 patients (18.4%). In the accelerated phase CML, results showed that 5 out of 35 (14.3%) patients achieved normalization of white blood cell counts or no evidence of CML within 2.3 months.

The most commonly reported side effects during the clinical trials include thrombocytopenia (low levels of platelets in the blood), anemia (low red blood cell count), lymphopenia (decrease in the lymphocyte count in the blood), neutropenia (reduction in white blood cells that fight infection), weakness, fatigue, nausea, Diarrhea and reaction at infection site.

"Teva is pleased to bring Synribo to the market for patients who need additional treatment options when others have failed," said Dr. Michael R. Hayden, Teva president.

The complete prescribing information for Synribo is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203585lbl.pdf