Genasense

Treatment for Chronic Lymphocytic Leukemia

Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J., February 6, 2007 -- Genta Incorporated today announced that the Company will appeal the non-approvable notice from the Food and Drug Administration's (FDA) Office of Oncology Drug Products of its New Drug Application (NDA) for the use of Genasense (oblimersen sodium) Injection plus chemotherapy in patients with chronic lymphocytic leukemia (CLL). The appeal will be filed pursuant to the Formal Dispute Resolution process that exists within FDA's Center for Drug Evaluation and Research (CDER). The Company filed notice reserving its rights to appeal in December 2006 and expects to complete the filing of this appeal during the current calendar quarter.

Genasense in CLL

In the pivotal Phase 3 trial, patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial - the first randomized study ever conducted in this population - achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR) (17% vs. 7%; P=0.025). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but will exceed 36+ mos. in the Genasense group vs. 22 mos. for patients treated with chemotherapy alone).

Prior to randomization on this trial, patients were prospectively stratified according to criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Clear trends, evident across all strata, suggested that the best response to Genasense occurred in patients who had received less extensive therapy. In addition to achieving the prospectively defined, intent-to-treat primary endpoint, patients in the Genasense group who were protocol-defined as "non-refractory" to fludarabine (comprising more than 40% of the total population) achieved:

  • A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016)
  • Increased time-to-progression (median = 12 mos. vs. 10 mos.; P = N.S.)
  • Increased overall survival (median not reached but exceeding 39+ mos. vs. 33 mos.; P = 0.05)

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

Posted: February 2007

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Genasense (oblimersen sodium) FDA Approval History

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