Wyeth Submits NDA and MAA for Cancer Drug

Wyeth Pharmaceuticals has submitted an NDA to the FDA and a marketing authorization application (MAA) to the EMEA for Torisel for the treatment of patients with advanced renal cell carcinoma (RCC).

The registration dossier contains interim data from a Phase III trial of 626 patients who had received no prior systemic therapy. The primary end point of the study was overall survival. The results showed treatment with Torisel increased median survival by 3.6 months, or 49%, compared with treatment with interferon-alpha (10.9 months vs. 7.3 months). The final analysis will also be submitted to regulatory authorities at a future date.

Torisel is an investigational drug that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a protein that regulates cell proliferation, cell growth and cell survival. If approved, Torisel would be the first agent in this class indicated for the treatment of a cancer.

In July 2004, the FDA granted fast track designation for Torisel for first-line poor prognosis subjects with advanced RCC, and in December 2004 it was granted orphan drug designation for the treatment of RCC. In March 2006, Torisel received Orphan Medicinal Product designation for the treatment of RCC in the EU.