HACKENSACK, N.J. -- A new drug shown to prolong the lives of women who have metastatic breast cancer has been approved by the Food and Drug Administration.
Halaven, a new injection treatment synthetically created based on a sea sponge, was developed by Woodcliff Lake-N.J.-based Eisai Inc. 5/8In a multicenter study of 762 patients, those taking the drug lived a median of 2.5 months longer than those not given the medicine. Overall survival was slightly 5/8more than 13 months, compared with 10 1/2 months for those who did not receive it.
The FDA approved Halaven for patients with metastatic breast cancer who have previously undergone at least two chemotherapy treatments for early or advanced breast cancer. The drug binds to the proteins that help cells divide, slowing the progression of the disease.
"Many women with metastatic breast cancer see their disease progress after receiving multiple therapies," said Dr. Linda Vahdat in a written statement. Vahdat is a professor of medicine with the division of hematology and medical oncology at the Iris Cantor Women's Health Center at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City. "Now, with the approval of Halaven, we can offer a new option that has been shown to improve survival in women with metastatic disease."
Twenty-five percent of the patients treated with Halaven reported side effects that included low counts of white and red blood cells, weakness and fatigue, hair loss, numbness, tingling or burning in the hands and feet, and nausea and constipation.
"This approval is encouraging news for women with metastatic breast cancer," said Liz Thompson, president of Susan G. Komen for the Cure, in a written statement. "This is a challenging disease, and the possibility of improved survival is meaningful to patients and their families."
Two-and-a-half months might not seem like a lot of time to healthy people but "it's a big deal to patients," said Dr. Alton Kremer, senior vice president and global head of clinical development for oncology at Eisai.
"You need to step into the reality of patients -- most of these women at this stage have less than a year to live so this is a quarter of their life expectancy," Kremer said. "It might mean one more holiday season or the chance for a grandmother to see her grandson walk for the first time. Now we're looking to see if this medicine can be used earlier in the disease."
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