(Updates to add FDA appeal hearing June 28 to 29.)
June 4 (Bloomberg) -- Roche Holding AG’s Avastin delayed progression of ovarian cancer and cut the rate of death in some women with the disease in two studies. They didn’t show that the $58,000-a-year therapy could improve survival.
In one trial, Avastin combined with chemotherapy delayed by four months the growth of cancer in women whose ovarian tumors had returned. A subgroup of the second study showed 79 women taking Avastin died, compared with 109 among those treated only with chemotherapy. The data was released today at the meeting of the American Society of Clinical Oncology in Chicago.
The results have renewed debate over whether Avastin, the world’s best-selling cancer drug, offers enough benefits to merit U.S. marketing approval for use in the disease given its side effects and costs. Use in ovarian cancer could help stem a decline in sales. U.S. regulators on Dec. 16 said they intended to revoke the drug’s conditional approval for use in breast cancer, citing lack of survival benefit. Roche appealed and a hearing will be held June 28-29.
“There has to be very careful consideration of the costs and benefits because the drug is quite expensive,” said George Coukos, director of the University of Pennsylvania’s Ovarian Cancer Research Center, in a telephone interview. “It depends on the margin of benefit one draws and the cost that society is willing to pay for that margin,”
The data presented today will be used by Basel, Switzerland-based Roche to seek approval for treating ovarian cancer, said Philippe Bishop, head of Avastin clinical development for the Swiss drugmaker.
$6.2 Billion in Sales
Avastin, developed by Roche’s South San Francisco, California-based Genentech unit, generated revenue of $6.2 billion last year as a treatment for colorectal, brain, lung and kidney tumors. It reached the market in 2004 as the first medicine cleared to halt cancer growth by blocking a tumor’s blood supply.
Ovarian cancer is rarely found in the early stages. By the time it’s detected, it usually has spread outside the ovaries. The average life span for women with advanced cancer is 2 1/2 to 3 years from the time the tumor is discovered, Coukos said in a telephone interview. He wasn’t involved in either study.
About 21,880 U.S. women were diagnosed with the disease in 2010 and 13,850 died, according to the American Cancer Society.
One study followed 1,528 women newly diagnosed with high- risk ovarian tumors. Half were treated with chemotherapy and Avastin, followed by a year’s worth of Avastin, and the rest were treated by chemotherapy alone.
After 28 months, 178 of the women who got both treatments had died, compared with 200 of the women taking chemotherapy only. Those results weren’t statistically significant. In a sub- group of patients at highest risk, 79 women in the Avastin group died, compared with 109 deaths among the patients treated only with chemotherapy.
While the study is ongoing and the results are preliminary, the findings in the smaller group of patients are considered statistically significant, Bishop said.
The other study compared Avastin and chemotherapy with chemotherapy alone in 484 women whose cancer had returned after being treated with a previous round of chemotherapy. The women who received both treatments went a median of 12.4 months before their tumors grew, compared with 8.4 months in women who got chemotherapy alone. The tumors shrank in 79 percent of the women getting the combination and in 57 percent of those who were only given chemotherapy.
“This is good news for women with ovarian cancer,” said study leader Carol Aghajanian, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York. The drug “helps make ovarian cancer more of a chronic disease.”
--Editors: Angela Zimm, Reg Gale
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