The drug, which is similar to Bristol-Myers Squibb Co.'s (BMY) Taxol, was approved last January to treat advanced breast cancer in patients who've failed other treatments.
Abraxis, however, eventually wants to seek FDA approval to market Abraxane as a treatment for earlier-stage breast cancer and had proposed partly using studies of Taxol to support such an indication.
Taxol is approved for use in both early and late-stage breast cancer. While Abraxane has the same active ingredient as Taxol, the FDA said the formulations of the drugs are different.
The agency brought the issue before its outside panel of cancer experts for advice on whether Abraxis should be required to conduct its own study of Abraxane in early-stage breast cancer patients rather than using Taxol studies.
The panel voted 13 to 1 in favor of additional study. The FDA typically follows its panel's advice but is not required to.
In a statement, Michael J. Hawkins, Abraxis BioScience's chief medical officer, said the company would "move as quickly as possible" to discuss next steps with the FDA in order to design a study in hopes of receiving approval "in this indication earlier than typically expected."
In recent trading shares of Abraxis were at $25.05, unchanged.
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