GenasenseTreatment for Chronic Lymphocytic Leukemia
FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia
Extension Associated with Submission of New Data Analyses
BERKELEY HEIGHTS, N.J., October 30, 2006 -- Genta Incorporated announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it has extended the review period for the currently pending New Drug Application (NDA) for Genasense (oblimersen sodium) Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has requested a meeting with FDA, and the Company has submitted additional data analyses in support of the application. The FDA has indicated that submission of the new information comprises a major amendment to the NDA and has elected to extend the review period for 90 days to January 29, 2007.
"We are pleased that the FDA has agreed to consider this new information during their review of the Genasense NDA," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "Our pivotal trial met its primary endpoint in the only controlled clinical trial ever conducted in this patient population. Genasense significantly increased the number and length of durable complete remissions, an endpoint that has consistently defined clinical benefit in leukemia. Our new analyses reinforce that conclusion, and we look forward to continued dialog with FDA regarding this application. 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."
The Genasense NDA was reviewed at a meeting of the FDA's Oncologic Drug Advisory Committee meeting on September 6, 2006 where it failed to receive a majority vote to recommend approval.
Genasense in CLL
The NDA for Genasense was based on two separate clinical trials. The first was a Phase 1-2 trial that demonstrated the safety and activity of the drug used as a single-agent in 40 patients who had received extensive anti- leukemic therapy. The second trial was a randomized, multicenter, multinational trial in which 241 patients with relapsed or refractory CLL received standard chemotherapy (fludarabine plus cyclophosphamide) with or without Genasense. The trial met its primary endpoint, which was the demonstration of a statistically significant increase in the proportion of patients who achieved complete or nodular partial remission. Patients with this level of remission have no overt evidence of leukemia. Moreover, these remissions were durable (greater than 6 months in duration), they were associated with significant improvement in signs and symptoms of leukemia, and they lasted significantly longer when induced with Genasense compared with chemotherapy alone.
Adverse events that were significantly higher in the Genasense group included (but were not limited to) thrombocytopenia, nausea, fever, fatigue, back pain, weight loss, dehydration, and intravenous catheter complications. However, serious adverse events that resulted in discontinuation of therapy were equal between the treatment arms.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. According to the American Cancer Society, approximately 8,000 patients will be diagnosed this year, and more than 60,000 people are living with CLL in the United States. The disease arises in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions. Patients with CLL typically develop symptoms that may progress over a period of years, ultimately producing a generalized depression of immunity, marked increases in the size of spleen, liver and lymph nodes, and impaired production of other normal blood cells. Eventually, these problems may cause life-threatening complications, such as overwhelming infections and fatal bleeding.
Posted: October 2006
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