FDA grants Favrille's FavId fast track status for treatment of non-Hodgkin's lymphoma

By E. Janene Geiss

Philadelphia, Jan. 12 - Favrille, Inc. said that the Food and Drug Administration has granted fast track designation for FavId, the company's lead product candidate for the treatment of B-cell follicular non-Hodgkin's lymphoma.

FavId currently is in a pivotal phase 3 clinical trial following Rituxan therapy in patients with follicular B-cell non-Hodgkin's lymphoma, according to a company news release.

"This decision by the FDA has the potential to save us valuable time in the regulatory approval process and also serves as an important acknowledgment of the potential for FavId in the treatment of B-cell follicular NHL," John P. Longenecker, president and chief executive officer, said in the release.

Under the FDA Modernization Act of 1997, a fast track designation means that FDA will expedite the development and review of a fast track product. The FDA may also evaluate for filing and start review of portions of an application for approval of a fast track product.

Favrille said it recently reported positive long-term follow-up data from its phase 2 clinical trial of FavId at the American Society of Hematology annual meeting.

The data suggests that administration of FavId following Rituxan in patients with follicular B-cell non-Hodgkin's lymphoma appears to improve the response rate over Rituxan alone and extend time to disease progression compared to historical data, officials said. The data also compare favorably with previous immunotherapy studies.

Favrille said it is nearing completion of patient enrollment in its randomized, double-blind, placebo-controlled phase 3 registration trial. The company initiated the trial in July 2004 with a target of 342 eligible patients, officials said.

Favrille said it anticipates an analysis of a secondary endpoint of the trial, response improvement, during the fourth quarter of this year. The final analysis of the primary endpoint of the trial is expected during the second half of 2007, officials said.

Favrille is a San Diego biopharmaceutical company focused on the research, development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system.

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