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J&J’s Zytiga Wins Approval for Early Prostate Cancer Use

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Dec. 10 (Bloomberg) -- Johnson & Johnson won U.S. approval for its prostate cancer pill Zytiga to be used earlier in the disease, possibly spurring four times as many patients to take the medicine.

Zytiga can be prescribed before chemotherapy in men whose prostate cancer has spread to other parts of the body and is resistant to testosterone-lowering treatments, the Food and Drug Administration said today in a statement. The drug extends survival when given before chemotherapy and prolongs the time before patients seek chemotherapy and pain treatments, Michael Meyers, J&J’s development team leader for Zytiga, said by phone.

The approval may expand use by as much as fourfold, Meyers said. About 20,000 men in the U.S. have used the drug from New Brunswick, New Jersey-based J&J since it was cleared in April 2011. The treatment may reach sales of $1.7 billion in 2016, the average of four analysts’ estimates compiled by Bloomberg.

“As we move into earlier stages of disease, what we’re doing is not only prolonging survival, what we are doing is prolonging the time that men with metastatic castration-resistant prostate cancer have good quality of life and are able to maintain their functioning,” Meyers said.

Prostate cancer is the second-leading cause of cancer death in American men behind lung cancer. About 241,700 new cases will be diagnosed this year and almost 28,200 men will die of the disease, according to the American Cancer Society.

J&J rose less than 1 percent to $70.59 at the close of New York trading.

Tumor Growth

Zytiga decreases the production of testosterone, which stimulates prostate tumors to grow, the FDA said.

Patients in a clinical study who took Zytiga for its new use along with a steroid lived a median of 35.3 months, or 5.2 months longer than those who took a sugar pill in combination with steroids, according to the FDA’s statement. Patients on Zytiga hadn’t experienced further tumor growth during the study while those on the sugar pill saw growth after a median of 8.3 months.

Zytiga generated $697 million in sales in the first nine months of 2012, Joaquin Duato, J&J’s worldwide chairman of the pharmaceuticals group, said in an Oct. 16 earnings call. Dendreon Corp.’s Provenge is approved for a similar use and could be used with Zytiga and in sequence, Meyers said.

Medivation Inc.’s Xtandi was cleared in August by the FDA for patients whose disease has advanced beyond the prostate even with previous treatments. The San Francisco-based company’s shares rose 3.1 percent to $55.33.

J&J is studying Zytiga in men with prostate cancer who haven’t yet received hormonal therapy, Meyers said.

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Reg Gale at

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