Prostate cancer drug extends life in study

Johnson & Johnson's experimental prostate-cancer drug, abiraterone, slowed the disease and extended lives, according to a company-sponsored study.

The trial involved 1,195 patients with advanced prostate cancer that was spreading after treatment with one or two chemotherapy regimens. Patients who received abiraterone, with the steroid prednisone, lived a median of 3.9 months longer than those treated with prednisone alone, the researchers found. The results were presented Monday at the European Society for Medical Oncology meeting in Milan.

The research is part of the last of the three stages of testing usually needed for regulatory approval. J&J, based in New Brunswick, N.J., may file a new-drug application with federal regulators by early 2011 on the basis of the study results, Larry Biegelsen, an analyst at Wells Fargo Securities in New York, said in a note to clients last week.

Abiraterone, which J&J acquired in its $878 million purchase of Cougar Biotechnology in July 2009, stops tumor cells from making a hormone they need to survive and reproduce.

The National Cancer Institute estimates that 217,730 men in the United States will be diagnosed with prostate cancer this year and about 32,000 will die of it. The disease is the second-leading cause of cancer death in American men, after lung cancer, according to the American Cancer Society, based in Atlanta.

J&J revealed which patients in the study were getting abiraterone in August after an interim analysis showed the medicine prolonged survival and had an acceptable safety profile.

Patients getting the drug lived two extra months without their tumors' growing, the data showed. Their median survival was 14.8 months, compared with 10.9 months for placebo. Fluid retention, low blood-potassium levels and heart disorders were more common among those taking abiraterone.

Patients in the trial who were assigned to get a sugar pill were offered the J&J treatment. A program to provide early access to other people who meet certain criteria also is expected to begin in the U.S. this month, Ortho Biotech Oncology Research & Development, a division of J&J, said.

"The treatment works really well - it's exciting," said Howard Scher, chief of genitourinary oncology at Memorial Sloan-Kettering Cancer Center in New York and the study's co-lead investigator, in a phone interview Monday.

Another treatment for prostate cancer, Seattle-based Dendreon Corp.'s Provenge, helped patients live 4.1 months longer than those given a placebo in tests used to gain approval. Comparisons between the two drugs are difficult, because the J&J drug was tested in sicker patients who had failed on at least one chemotherapy, Scher said. In the Provenge study, patients in the placebo group lived 21.7 months.

Provenge, the first drug designed to train the body's immune system to fight cancer, was cleared for sale in April. It costs about $93,000 for three doses administered over the course of a month, while abiraterone may be priced at $27,000 annually, Biegelsen said.