June 17, 2010 / 6:29 PM / 9 years ago

UPDATE 3-US FDA OKs Sanofi-Aventis prostate cancer drug

* Drug extends survival by two and a half months

* $295 mln in sales by 2014 -Thomson Reuters estimate (Adds comments from Chew)

By Jon Lentz

WASHINGTON, June 17 (Reuters) - The U.S. Food and Drug Administration approved Sanofi-Aventis SA’s (SASY.PA) SNY.N new chemotherapy drug for advanced prostate cancer on Thursday.

Jevtana extended by nearly 2-1/2 months the lives of men with prostate cancer tumors that resist standard treatment with hormones and other chemotherapy, a company study had showed.

The drug is the first to be effective in such difficult-to-treat cases, a researcher for the study said.

“The problem has been what to do when the disease advances,” said Oliver Sartor, a medical researcher at Tulane University and lead author of the company’s major study of the drug. Jevtana “is the only effective drug in this space.”

Prostate cancer is the second most common cancer in men worldwide after lung cancer, killing 254,000 men a year.

In a sign of the potential impact of the drug, the FDA conducted a quicker six-month review of Jevtana used for innovative drugs that may provide treatment where none exists. The approval came months ahead of the agency’s Sept. 30 deadline.

“We hope that we will have it available in the summer,” said Paul Chew, the chief science officer and chief medical officer of Sanofi-Aventis’s U.S. unit. “We are delighted that the FDA was able to approve it so quickly.”

The French drugmaker’s shares closed down 12 cents, or about 0.4 percent, to $31.72 on the New York Stock Exchange.

The approval comes shortly before Sanofi-Aventis loses patent protection on its blockbuster cancer medicine Taxotere in November.

Jevtana is expected to generate worldwide sales of $295 million by 2014, according to consensus analyst forecasts compiled by Thomson Reuters.

That compares with 2009 worldwide Taxotere sales of $3 billion.

Analysts believe the new drug is likely to fetch a similar price to Taxotere, at around $2,500 per cycle of treatment.

Other studies are planned to assess the effectiveness of Jevtana earlier in the course of prostate cancer treatment, before patients stop responding to Taxotere.

In the company’s single major study, Jevtana reduced deaths by 28 percent among men with cancer that had already spread beyond the prostate.

The agency approved the intravenous drug despite a small but heightened risk of death from side effects.

Like other chemotherapy drugs, Jevtana reduced white blood cell counts and will require careful monitoring of patients to minimize side effects, Sartor told Reuters in an interview on Wednesday.

Other side effects include anemia, reduced levels of platelets in the blood, nausea and fatigue.

The company study tested 755 men who were randomly assigned to receive the drug plus a steroid, or another chemotherapy drug plus a steroid. The study found that the drug reduced the risk of death by 28 percent overall.

The median survival period for the men treated with Jevtana was 15.1 months compared to 12.7 months for a standard chemotherapy treatment. Nearly 5 percent died from side effects after treatment with the drug, compared to nearly 2 percent in the comparison group, the company has reported.

“This is the first and only therapy to provide a significant survival benefit in one of the most difficult to treat populations,” Chew said. (Reporting by Jon Lentz, editing by Gerald E. McCormick and Carol Bishopric)

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