Wyeth Pharmaceuticals, a division of Wyeth, announced that the US 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 tumour 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.
Renal cell carcinoma accounts for approximately 85 percent of kidney cancers. The American Cancer Society estimates that 51,190 new cases of kidney cancer will be diagnosed this year, and more than 40 percent of patients will be diagnosed initially with advanced disease.
The pivotal study of Torisel showed that in 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, an active comparator that has been the clinical standard of care. The most common adverse events (incidence = 30 percent) in patients treated with Torisel or with interferon-alpha were asthenia (weakness), rash, anaemia, edema, nausea and anorexia (loss of appetite).
"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 labelling for launch in the third quarter of 2007," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research, and Senior Vice President, Wyeth. "We believe that Torisel has shown the potential in clinical trials to be an important therapeutic option for patients with advanced renal cell carcinoma."
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).
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.