Bristol Breast Cancer Drug Granted Priority FDA Review
U.S. health regulators have granted priority review for Bristol-Myers Squibb experimental breast cancer drug ixabepilone, and an approval decision on the medicine could come by late October, the company said on Tuesday.
With priority review status, the Food and Drug Administration will make its decision on whether to approve the drug within six months, rather than the usual 10- to 12-month review period. The agency grants priority review to products that are considered to be potentially significant advancements over existing therapies.
Bristol-Myers is seeking approval for ixabepilone to treat advanced breast cancer patients who have not responded to prior treatment with chemotherapies.
In data from a clinical trial presented earlier this month at a major cancer meeting, ixabepilone and chemotherapy were significantly better than chemotherapy alone in delaying progression of advanced breast cancer.
Following treatment, 35 percent of those receiving the drug combination experienced at least a 50 percent reduction in tumor size. That compared with 14 percent of patients receiving chemotherapy alone. The better result was highly statistically significant, meaning it was compelling.
Ixabepilone belongs to a new class of drugs called epothilones that Bristol-Myers hopes will prove better able than standard drugs to thwart resistance by tumors.
The drug is a semi-synthetic version of a compound isolated from an African soil sample.