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FDA gives nod to drug for kidney cancer


The FDA recently approved temsirolimus (Torisel, Wyeth) for the treatment of advanced kidney cancer.

"Torisel shows promise in treating RCC-a hard tumor to treat," added James Trovato, Pharm.D., MBA, BCOP, associate professor of pharmacy practice at the University of Maryland School of Pharmacy. "It will probably be used as a first-line agent for patients with poor prognostic factors such as advanced or metastatic disease."

The results showed that temsirolimus significantly improved median overall survival, the primary endpoint, compared with alpha interferon. The combination group did not show a significant increase in overall survival compared with the alpha interferon group. Temsirolimus also demonstrated a significant benefit in median progression-free survival, a secondary endpoint, compared with alpha interferon.

According to the product labeling, the most common adverse reactions observed with temsirolimus are rash, asthenia, mucositis, nausea, edema, and anorexia. Hypersensitivity reactions have been observed with temsirolimus. "With alpha interferon, we see many intolerant side effects; with Torisel, we see fewer," said O'Bryant.

In the phase III clinical trial, grade 3 or 4 adverse events occurred in 67% of the patients in the temsirolimus group compared with 78% of the patients in the alpha-interferon group. The manufacturer recommends monitoring patients for the occurrence of infections, including opportunistic infections, because temsirolimus may cause immunosuppression.

Pharmacokinetic studies show that strong inducers and inhibitors of CYP3A4 may affect concentrations of temsirolimus' primary metabolite. According to Wyeth, if alternatives can't be used, a dose reduction to 12.5 mg/week should be considered when used with strong CYP3A4 inhibitors and a dose increase from 25 mg/week up to 50 mg/week should be considered when used with strong inducers of CYP3A4.

The recommended dose of temsirolimus for advanced RCC is 25 mg infused over a 30- to 60-minute period once a week. Treatment should continue until disease progression or unacceptable toxicity occurs.

Temsirolimus must be stored under refrigeration and protected from light. According to the labeling, the vial contents must first be diluted with the enclosed diluent before diluting the resultant solution with 250 ml of 0.9% sodium chloride solution in non-DEHP containers and administered through polyethylene-lined administration sets. The stability of temsirolimus in other solutions has not been studied.


THE AUTHOR is a writer based in New Jersey.

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