FDA approves Teva's Synribo for CML; Novartis plans for Tasigna switch

The US Food and Drug Administration on Friday approved Israel-headquartered Teva Pharmaceutical Industries’ (NYSE: TEVA) Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.

Teva, best known as the world’s largest generic drugmaker, acquired rights to the drug along with its $6.8 billion acquisition of US biotech firm Cephalon, which itself had purchased omacetaxine’s originator, Australia-based ChemGenex (The Pharma Letters passim).

An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML. Synribo blocks certain proteins that promote the development of cancerous cells. It is injected just under the skin (subcutaneously) twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalize (hematologic response). Synribo is then administered twice daily for seven consecutive days over a 28-day cycle as long as patients continue to clinically benefit from therapy.