Torisel Approval Delayed by FDA; May Find a Role in NHL

[Guest guest]

[This drug (temsirolimus) has been tested in NHL, includingn

CLL/SLL, where it showed some activity, though no remissions. It

showed more promise in follicular NHL and other lymphomas.]

Wyeth Provides Update on FDA Review of the Torisel New Drug

Application

COLLEGEVILLE, Pa., April 6 /PRNewswire-FirstCall/ -- Wyeth

Pharmaceuticals, a division of Wyeth , announced that the U.S. Food

and Drug Administration (FDA) has extended the review of the New

Drug Application (NDA) for Torisel (temsirolimus), Wyeth's

investigational treatment for advanced renal cell carcinoma (RCC).

The NDA for Torisel originally was submitted on October 5, 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. On April 5, 2007, the FDA confirmed that as

a result of this amendment, the action date for the NDA has been

extended by three months, to July 2007, to allow the agency time to

complete a full review of these analyses.

About Torisel

Torisel was designed to inhibit the mTOR (mammalian target of

rapamycin) kinase, a protein within all cells that regulates cell

proliferation, cell growth and cell survival. If approved, Torisel

will be the first mTOR inhibitor for the treatment of a cancer.

During the extended review period, Wyeth will continue to make

Torisel available in the United States to patients who meet certain

criteria through an Expanded Access Program (EAP). For more

information about the Torisel EAP in the United States, patients and

health care providers can call (800) 234-8423.

Wyeth Pharmaceuticals