FDA has extended its review of Wyeth's investigational kidney cancer drug Torisel (temsirolimus) by three months to review additional information on tumor evaluation, the firm announced April 6.

Wyeth recently submitted the information at the agency's request, the company said. The NDA was filed with FDA Oct. 5 and was granted priority review; it originally had an April 5 action date (¹ Also see "Wyeth Submits NDA For Temsirolimus In Kidney Cancer" - Pink Sheet, 5 October, 2006.).

The company has requested labeling for advanced renal cell cancer. With that indication, Torisel would compete against Bayer's Nexavar (sorafenib), approved in December 2005, and Pfizer's Sutent (sunitinib), which received FDA approval in January 2006 for advanced RCC.

As a cell-signaling inhibitor that works through the mammalian-targeted rapamycin (mTOR) pathway, Torisel has a novel mechanism of action that Wyeth believes will offer the oncologic an advantage in the RCC space.

"While it's not the first drug for kidney cancer, it's the first drug that prolongs survival ... [and it] ... does that by 50 percent," Wyeth VP-Pharmaceutical Research and Development Robert Ruffolo said in an ² Also see "Wyeth R&D President Robert Ruffolo: An Interview With “The Pink Sheet” DAILY" - Pink Sheet, 4 April, 2007. with "The Pink Sheet" DAILY before the FDA extension.

Similar to other RCC drugs, Torisel improves progression-free survival, but it also improves overall survival, Ruffolo said. In addition, it "improved quality of life over the standard of care," he noted.

Ruffolo said Wyeth plans to study Torisel in combination with Nexavar and with Sutent and has begun to study the drug as a treatment for mantle cell lymphoma.

The exec added that Wyeth is "all set up to go," and a Torisel launch could occur within "a month or so" of approval. The firm now anticipates launching in the third quarter.

- Shirley Haley (s.haley@elsevier.com) and Jessica Merrill (j.merrill@elsevier.com)

Torisel Action Date Extended To July 5

More from Archive

More from Pink Sheet