New York Times examines efforts to obtain FDA approval for Abraxane to treat earlier-stage cancer

The New York Times has examined efforts by the pharmaceutical company Abraxis BioScience to obtain FDA approval for its late-stage breast cancer drug Abraxane as a treatment for earlier-stage breast cancer.

Abraxane costs $4,200 per dose and combines the drug paclitaxel, which destroys cancer cells, with albumin, a protein found in human blood.

A similar drug called Taxol—which was under patent by Bristol-Myers Squibb until 2000—combines paclitaxel with Cremophor, a combination of castor oil and alcohol. Generic versions of Taxol cost about $150 per dose.

According to the Times, patients taking Taxol receive a steroid and an antihistamine to reduce the risk that Cremophor will cause harsh allergic reactions.

Patients taking Abraxane do not need to take a steroid or antihistamine, and the drug can be given at higher doses than Taxol. In a clinical trial of 454 patients comparing the two drugs, Taxol prevented tumor growth for an average of 17 weeks, compared with 23 weeks for Abraxane.

About 75% of patients in both groups died two years after the study began. Similar side effects were found in both drugs, but more patients taking Taxol had low white blood cell counts compared with patients taking Abraxane, the Times reports.

Abraxis earlier this year asked FDA to waive a requirement that it submit data for a trial testing Abraxane on earlier-stage breast cancer patients.

Michael Hawkins, the company’s chief medical officer, told an FDA committee at a Sept. 7 hearing that the company should not have to conduct trials because testing likely would not show a difference between the drug and generic paclitaxel, which is approved for early stage breast cancer treatment.

The agency committee rejected the proposal 13-1, and the company said it expects to soon begin discussions on designing a clinical trial testing the drug on early-stage breast cancer patients, the Times reports.

About 20,000 late-stage breast cancer patients have been treated with Abraxane (Berenson, New York Times).