FDA Extends Review Period for Wyeth's Torisel NDA

Wyeth Pharmaceuticals announced that the FDA has extended the review of its new drug application (NDA) for Torisel, an investigational treatment for advanced renal cell carcinoma (RCC).

The NDA for Torisel (temsirolimus) was originally submitted in October 2006 and was granted priority review status. As part of the ongoing review, Wyeth recently submitted additional information on tumor evaluation, as requested by the FDA. Last week the FDA confirmed that as a result of this amendment the action date for the NDA has been extended by three months to July to allow the agency time to complete a full review of these analyses.

The pivotal study of Torisel showed that for patients with advanced RCC and poor prognostic features who had received no prior systemic therapy, Torisel significantly increased median overall survival, the primary endpoint, by 49 percent, compared with interferon-alpha.

"We are encouraged by the review process so far, and, with the submission of these analyses, we remain optimistic about the prospects for strengthening the product labeling for launch in the third quarter of 2007," Robert Ruffolo, president of Wyeth Research, said.

Torisel was designed to inhibit the mTOR kinase, a protein within all cells that regulates cell proliferation, cell growth and cell survival. If approved, Torisel will be the first mTOR inhibitor indicated for treating cancer.

During the extended review period, Wyeth will continue to make Torisel available in the U.S. to patients who meet certain criteria through an expanded access program.