FDA Panel Rejects Cell Therapeutics Drug Pixantrone
Last update: 3/22/2010 11:39:06 AM
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones
A Food and Drug Administration panel Monday unanimously rejected pixantrone, a proposed drug from Cell Therapeutics Inc. (CTIC) being developed to treat non-Hodgkin's lymphoma, saying there wasn't enough clinical evidence to show whether the drug worked.
Cell Therapeutics is seeking FDA approval of pixantrone to treat patients with non-Hodgkin's lymphoma whose disease has progressed after treatment with at least two other therapies.
The panel decision came after a negative review of the product by an FDA medical officer who said the agency was "left without a basis for approval."
The decision makes it likely the FDA will decide against approving the product. The main clinical study involving pixantrone was stopped early because doctors had a hard time recruiting patients into the trial.
Overall, the FDA said the results of the trial showed the drug has "biologic" activity, but the results weren't strong enough to support approval of the product. Researchers had hoped to enroll 320 patients into the study, but were only able to recruit 140 patients, including eight in the U.S. Half of the patients were given pixantrone while the other half were treated with other currently approved drugs.
The primary goal of the study was to look at the number of patients who achieved a confirmed or complete remission of the cancer. At the end of treatment, 14 patients receiving pixantrone achieved remission compared with four not receiving the drug.
A secondary goal looking at whether patients responded to the drug for at least four months showed 25.7% of patients in the pixantrone group achieved a so-called overall response compared with 8.6% of patients who didn't receive the drug.
The company said the results were considered statistically significant while the FDA said the results weren't significant because the analysis of the study wasn't adjusted to account for the study being stopped early with fewer patients than planned.
Cell Therapeutics said pixantrone would fulfill an unmet medical need for some patients whose disease returns after treatment with other types of currently approved drugs. Lymphoma is a type of cancer that originates in white blood cells known as lymphocytes. About 63,000 cases of non-Hodgkins lymphoma are diagnosed each year, according to the National Cancer Institute.
By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com (END) Dow Jones NewswiresMarch 22, 2010 11:39 ET (15:39 GMT)
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