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"We're really pleased that there were no new safety signals" and that pertuzumab is so promising, said Dr. Sandra Horning, Genentech's global development chief of cancer drugs.
Another study is testing pertuzumab in 3,800 women with early breast cancer. Genentech says it has not set a price for pertuzumab, but sells Herceptin for $4,500 a month to doctors, who mark it up and add fees to infuse it. Herceptin's U.S. patent expires in 2019, so combination treatment might be more affordable once generic Herceptin is available.
"Pertuzumab is a winner" and should win government approval, said Dr. Eric Winer of the Dana-Farber cancer center.
Dr. Gary Lyman, a treatment effectiveness researcher at Duke University, called the results "quite impressive," unlike what turned out to be the case for Avastin. He was on an FDA panel that recommended accelerated approval for Avastin as well as the recent panel that urged revoking its use for breast cancer because later studies did not bear out its early promise.
Winer and Lyman have no role in the new studies or financial ties to any drug companies.
The other study tested Novartis AG's Afinitor, which has long been sold for preventing organ rejection after transplants and to treat a few less common cancers including the type of pancreatic tumor that killed Apple founder Steve Jobs. It blocks one pathway cancer uses to spread. A one-month supply costs $11,000.
The 724 women in the study were worsening despite treatment with hormone-blocking medicines. They all were given one they had not taken before, and some also got Afinitor.
After about a year of follow-up, cancer progression was delayed 7 months in the group getting Afinitor and 3 months in the others.
"The two together have a much greater effect than you would expect from either alone," said study leader Dr. Gabriel Hortobagyi, breast cancer research chief at the University of Texas MD Anderson Cancer Center in Houston. "They snip two wires that are critical" for growth signals to continue, he said.
However, the combo led to more side effects -- mouth sores, anemia, shortness of breath, high blood sugar, fatigue and lung inflammation.
"I have patients who tell me how long they live is not as important as the quality of the remainder of their life, where other patients will do just about anything and will tolerate any toxic levels or side effects," Hortobagyi said. "This is clearly one additional option for patients."
The cancer conference is sponsored by the American Association for Cancer Research, Baylor College of Medicine and the UT Health Science Center.
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Cancer conference: http://www.sabcs.org/
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