|Genzyme Receives FDA Complete Response Letter|
|By Staff and Wire Reports|
|Tuesday, 06 October 2009 12:46|
Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.
In September, the FDA Oncologic Drugs Advisory Committee voted 9 to 3 that data from a randomized, controlled trial was necessary to establish the efficacy and safety of Clolar in the proposed adult AML indication. Genzyme had sought approval to expand the indication based on the findings from a single-arm trial in an adult AML population.
Genzyme intends to request a meeting with the FDA to discuss the optimal path forward, including what additional or ongoing studies may satisfy regulatory requirements.