FDA Approves Wyeth's Torisel For Treatment Of Advanced Kidney Cancer

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Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry;  Urology / Nephrology
Article Date: 31 May 2007 - 0:00 PDT


The US Food and Drug Administration (FDA) yesterday approved Wyeth's new drug Torisel (chemical name temsirolimus) for the treatment of renal cell carcinoma, the most common form of advanced kidney cancer.

The FDA approval was based on the results of a clinical trial published today in the New England Journal of Medicine.

The trial showed that patients who were given Torisel alone showed a significant improvement in overall survival of about three and a half months compared with patients who were only on interferon.

Torisel belongs to a class of drugs that inhibit enzymes that control the production, growth and survival of cells.

More specifically, it inhibits the mammalian target of rapamycin kinase, commonly known as mTOR, a protein kinase that controls cell growth, proliferation, motility, and survival. mTOR also regulates protein synthesis and transcription.

Director of the FDA's Center for Drug Evaluation and Research, Dr Steven Galson said:

"We have made significant advances in the battle against kidney cancer."

"Torisel is the third drug approved for this indication in the past 18 months, and one that shows an increased time in survival for some patients," he added.

In December 2005 the FDA approved sorafenib (Bayer's Nexavar), followed by sunitinib (Pfizer's Sutent) in January 2006.

The Torisel multicentre phase 3 trial took 626 patients and randomly assigned them to three groups. One group was given Torisel alone, another was given interferon alfa (Roche's Roferon-A) and the third group received Torisol and interferon combined.

None of the patients had been treated before the trial and they had all received a poor prognosis for metastatic renal-cell carcinoma.

The median overall survival for patients receiving Torisel alone was 10.9 months compared with 7.3 months for those who received only the interferon.

Also, progression-free survival in the Torisel alone group was 5.5 months compared to 3.1 months in the interferon alone gruop.

The Torisel and interferon combined group did not show a significant increase in overall survival compared to the interferon alone group.

The researchers concluded that:

"As compared with interferon alfa, temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis. The addition of temsirolimus to interferon did not improve survival."

The most common side effects among the Torisel patients included rash, fatigue, nausea, edema, loss of appetite and mouth sores. This occurred in at least 30 per cent of the patients who received the drug. The most common abnormalities as shown by laboratory tests included high levels of blood sugar, lipids and triglycerides, plus elevated kidney and liver blood tests, with lower than normal red cell, white cell and blood platelet counts.

Renal cell carcinoma accounts for around 85 per cent of the 51,000 people affected by adult kidney cancer in the US every year.

"Temsirolimus, Interferon Alfa, or Both for Advanced Renal-Cell Carcinoma."
Gary Hudes, Michael Carducci, Piotr Tomczak, Janice Dutcher, Robert Figlin, Anil Kapoor, Elzbieta Staroslawska, Jeffrey Sosman, David McDermott, István Bodrogi,Zoran Kovacevic, Vladimir Lesovoy, Ingo G.H. Schmidt-Wolf, Olga Barbarash, Erhan Gokmen, Timothy O'Toole, Stephanie Lustgarten, Laurence Moore, Robert J. Motzer, for the Global ARCC Trial.
N Engl J Med Volume 356:2271-2281, May 31, 2007, Number 22.

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click here to find out more about kidney cancer (from CancerConsultants.com).

Written by: Catharine Paddock
Writer: Medical News Today


Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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