New drugs for breast cancer and multiple myeloma won approval from the Food and Drug Administration on Friday, expanding options for patients in advanced stages of those diseases.
The breast cancer drug, Afinitor from Novartis, seems to expand the time that endocrine therapy can keep the disease in check. The multiple myeloma drug, Kyprolis from Onyx Pharmaceuticals, was approved for use when at least two other drugs have failed.
Afinitor was approved for use by a large segment of breast cancer patients — postmenopausal women with hormone receptor-positive disease. These women are often treated with drugs called aromatase inhibitors, which deprive the tumors of the hormone estrogen, which can fuel their growth.
But tumors can become resistant to those drugs. The addition of Afinitor appears to restore their effectiveness.
“It’s exciting,” said Dr. Melody Cobleigh, director of the breast cancer program at Rush University Medical Center in Chicago. “We have figured out a way that tumor cells become resistant to existing therapies and a way to reverse that resistance.”
The clinical trial that led to approval involved 724 women with advanced breast cancer that was no longer being controlled by either Femara or Arimidex, two aromatase inhibitors.
All the women were given a slightly different aromatase inhibitor called Aromasin, also known as exemestane. Some, chosen at random, also received Afinitor while the others got a placebo.
Cancer began to worsen in a median of only 3.2 months for the women who got exemestane plus the placebo. That is not surprising because the tumors were already resistant to aromatase inhibitors. But the patients who also received Afinitor went a median of 7.8 months before their disease began progressing.
Still, Dr. Harold J. Burstein, a breast cancer specialist at the Dana-Farber Cancer Institute in Boston, said the gains were modest, especially given that Afinitor can cause serious side effects like mouth sores and lung inflammation. “I don’t know that it’s one that is going to radically change the near-term face of advanced breast cancer,” he said.
Afinitor, known generically as everolimus, works by inhibiting a protein in the body called mTOR, which is involved in cell growth and other processes.
Afinitor is already on the market as treatment for kidney cancer and some rarer tumors. The approval for the much more common breast cancer could sharply increase sales of the drug, which were $318 million in the first half of this year.
“We feel very confident taking our sales forecast well above $1 billion in breast cancer,” David Epstein, the head of pharmaceuticals for Novartis, said on the company’s earnings conference call on Thursday.
Afinitor, a tablet, has a wholesale cost of about $7,500 for a 28-day supply, the company said. American depositary receipts of Novartis, which is based in Switzerland, fell 27 cents, to $57.09 on the New York Stock Exchange on Friday.
Kyprolis, the new drug for multiple myeloma, received accelerated approval, under which drugs for life-threatening diseases can be approved with less than the usually required evidence, subject to further study.
In a clinical trial with no control group, the drug significantly shrank tumors in 23 percent of patients who had relapsed after receiving at least two previous therapies.
Multiple myeloma is a cancer of the bone marrow. An estimated 21,700 people will get the cancer this year and 10,700 will die from it, according to the American Cancer Society.
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