FDA has extended the user fee date for Genta's investigational chronic lymphocytic leukemia treatment Genasense (oblimersen) 90 days to Jan. 29, after the company submitted new data analyses in support of the application.

"FDA has indicated that submission of the new information comprises a major amendment to the NDA and has elected to extend the review period," the Berkeley Heights, N.J.-based company said Oct. 30.

The firm also said it has requested a meeting with FDA.

Genta is seeking an indication for oblimersen injection plus chemotherapy for patients with relapsed or refractory CLL.

The company is likely looking to use the new analyses to encourage FDA to approve Genasense after the agency's Oncologic Drugs Advisory Committee voted seven to three that data from Genta's randomized Phase III trial of Genasense did not show substantial evidence of clinical benefit in relapsed/refractory CLL patients (¹ Also see "Genta CLL Agent Genasense Has Not Shown Clinical Benefit, FDA Panel Says" - Pink Sheet, 6 September, 2006.).

In the single pivotal trial, the Genasense arm was associated with a statistically significant benefit compared to the combination of fludarabine and cyclophosphamide alone on the trial's primary endpoint of a composite response rate, but it did not demonstrate a difference between the treatment arms with regard to time to tumor progression and overall survival.

In its latest announcement, Genta said "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."

The ODAC decision has drawn some criticism. In a Sept. 26 letter to FDA Office of Oncology Drug Products Director Richard Pazdur, Emil Freireich (M.D. Anderson) maintained that the committee "was comprised of specialists who frankly admitted having no experience" with CLL for its review (² Also see "Genta’s SPA OK, But Firm Waits For FDA" - Pink Sheet, 6 October, 2006.).

While the NDA is under review, Genta will provide Genasense at no cost to CLL patients in response to single-patient "compassionate use" requests.

-Jessica Merrill (j.merrill@elsevier.com)

Genasense User Fee Date For CLL Extended Following New Data Submission

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