Genzyme hoping to expand Clolar into adult AML

US biotechnology firm Genzyme has completed enrollment in a Phase II trial examining the safety and effectiveness of Clolar (clofarabine) in previously untreated, older adult patients with acute myelogenous leukemia who are unlikely to benefit from standard induction therapy. Data from this study are expected to provide substantial evidence for expanding the current product label into adult AML, the firm noted.

Genzyme has held preliminary discussions with the US Food and Drug Administration in advance of submitting a supplemental New Drug Application for clofarabine as an initial treatment in older adults with AML. The company expects to file the sNDA in the second half of next year.

The clinical trial, known as CLASSIC II, is designed to address a high unmet medical need among older AML patients who currently have limited treatment options. According to the American Cancer Society, each year approximately 6,500 people over the age of 60 are diagnosed with AML in the USA, Genzyme noted.