31.05.2007 – 04:35
FDA Approves TORISEL, a Targeted First-in-Class mTOR Inhibitor for the Treatment of Advanced Kidney Cancer
Collegeville, Pennsylvania (ots/PRNewswire)
- TORISEL Is Proven to Extend Overall Survival for People with Advanced Renal Cell Carcinoma -
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) has approved TORISEL(TM) (temsirolimus) for patients with advanced renal cell carcinoma (RCC). TORISEL is the first targeted renal cancer therapy proven to extend median overall survival versus interferon-alpha, an active comparator, in this patient population.
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 these patients are initially diagnosed with advanced disease. TORISEL is the only marketed cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a key protein in cells that regulates cell proliferation, cell growth and cell survival. Wyeth anticipates that TORISEL will be available to patients in July 2007.
As part of a postmarketing commitment, Wyeth has agreed to submit two completed study reports and data sets: one on a thorough QT prolongation study and one on an ongoing hepatic impairment study.
"Advanced renal cell carcinoma can be a devastating diagnosis for patients and their families because the disease is very difficult to treat," says Gary Hudes, M.D., Director, Genitourinary Malignancies Program, Fox Chase Cancer Center, Philadelphia, and lead investigator of the phase 3 trial of TORISEL in advanced RCC. "Developing effective treatments for this stage of disease is a major challenge. Temsirolimus is the first drug to demonstrate a significant increase in overall survival for patients with the most aggressive form of kidney cancer, providing us with a new and much needed option for treatment."
In a three-arm, phase 3 clinical trial of 626 patients with advanced RCC and poor prognosis who had received no prior systemic therapy, TORISEL significantly increased median overall survival by 49 percent compared to interferon-alpha (10.9 months vs. 7.3 months, P=0.0078). TORISEL also was associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival (when the disease does not get worse; 5.5 months vs. 3.1 months, P=0.0001). The combination of TORISEL and interferon-alpha did not result in a significant increase in overall survival when compared with interferon-alpha alone.
"The approval of TORISEL for the treatment of advanced renal cell carcinoma reinforces the potential of mTOR inhibition as a new approach in oncology. This milestone demonstrates Wyeth's commitment to developing innovative therapies for cancer. In addition to TORISEL, we have five oncology treatments currently in human trials for various cancers, and we are dedicated to research into new therapies that have the potential to address unmet medical needs," says Robert R. Ruffolo, Ph.D., President, Wyeth Research.
TORISEL is an mTOR inhibitor indicated for the treatment of advanced RCC. In in vitro studies using cancer cells, mTOR inhibition blocked the translation of genes that regulate the cell cycle. mTOR inhibition also resulted in reduced levels of certain cell growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor.
Important Safety Information
Hypersensitivity reactions manifested by symptoms, including, but not limited to anaphylaxis, dyspnea, flushing, and chest pain have been observed with Torisel.
The use of Torisel is likely to result in increases in serum glucose. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy. The use of Torisel is likely to result in increases in serum triglycerides and cholesterol. This may require initiation, or increase in the dose, of lipid-lowering agents.
The use of Torisel may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections.
Cases of interstitial lung disease, some resulting in death, have occurred with Torisel. Some patients were asymptomatic and others presented with symptoms and required discontinuation of Torisel treatment and/or corticosteroids, and/or antibiotics.
Bowel perforation may occur. Evaluate fever, abdominal pain, bloody stools and/or acute abdomen promptly.
Renal failure, sometimes fatal, has occurred. Monitor renal function at baseline and while on Torisel.
Due to abnormal wound healing, use Torisel with caution in the perioperative period.
Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes) while receiving Torisel.
Live vaccinations and close contact with those who received live vaccines should be avoided.
Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant.
The most common (incidence greater than or equal to 30%) adverse reactions observed with Torisel are: rash, asthenia, mucositis, nausea, edema, and anorexia. The most common laboratory abnormalities (incidence greater than or equal to 30%) are anemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymphopenia, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia.
Strong inducers of CYP3A4/5 and inhibitors of CYP3A4 may affect concentrations of the primary metabolite of Torisel. If alternatives cannot be used, dose modifications of Torisel are recommended.
Please see TORISEL full prescribing information at http://www.wyeth.com.
TORISEL Development Program
Wyeth continues to study TORISEL in a phase 3 trial of patients with mantle cell lymphoma, which is an aggressive type of B-cell non-Hodgkin's lymphoma, and the Company is pursuing several additional studies in RCC. Additional oncology trials with TORISEL are being conducted through a cooperative research and development agreement with the National Cancer Institute in several other tumor types.
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, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals , Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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