The FDA said the review period had been extended due to major amendments made by Genta to the drug application after it was submitted. The evaluation period will be extended for 90 days to January 29, 2007 in order to examine the new data that was put forward.
“While the NDA remains under active review, we will continue to provide Genasense at no cost to CLL patients in response to single patient, ‘compassionate use’ requests,” commented Dr Loretta Itri, Genta’s Chief Medical Officer.
The Genasense new drug application was reviewed at a meeting of the FDA’s Oncologic Drug Advisory Committee meeting on September 6, 2006 where it failed to receive a recommended approval.
The new drug application for Genasense was based on two separate clinical trials. The first was a trial that demonstrated the safety and activity of the drug. The second was a trial in which patients with relapsed or refractory chronic lymphocytic leukemia received standard chemotherapy with or without Genasense.
The trial demonstrated a significant increase in the proportion of patients who achieved complete or partial remission. Moreover, these remissions were durable, associated with significant improvement in signs and symptoms of leukemia, and they lasted significantly longer when induced with Genasense compared with chemotherapy alone.