FDA grants Wyeth drug priority review

A priority designation accelerates review of the drug and is often given to a drug that, if approved, would be a significant improvement compared with existing treatments. The FDA previously granted fast track designation and orphan drug status for investigational Torisel for the treatment of advanced renal cell carcinoma.

Torisel is an investigational drug that specifically inhibits the mTOR kinase, a protein that regulates cell proliferation, cell growth and cell survival. The registration dossier contains interim data from a phase III trial of patients who had received no prior systemic therapy. The results showed that Torisel significantly increased overall survival by 49% in patients with advanced renal cell carcinoma compared with interferon-alpha, an existing treatment for renal cell carcinoma.

In the US, Torisel will be available prior to FDA approval through an expanded access program.