Abraxis Drug Needs More Data

Advisers to the U.S. Food and Drug Administration Thursday said approval of Abraxis’ breast-cancer drug Abraxane needs more data.

An FDA advisory panel met Thursday to give its input on whether Abraxis had submitted enough evidence that Abraxane is safe and effective for the adjuvant treatment of node-positive breast cancer.

The panel voted that the company needs to conduct a reasonably sized randomized trial before it can recommend FDA approval of the injectable treatment.

The FDA is not bound to follow the advice of its advisory panels but does so in most cases.

Abraxis issued a statement on the news of the panel’s vote saying, We are encouraged by the … panel’s recommendation and we intend to move as quickly as possible to discuss the next steps with the FDA.

Abraxane was previously approved to treat breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

The injectable drug’s active ingredient is paclitaxel, but it also uses a human protein called albumin that eliminates the need for the solvents contained in many chemotherapy drugs, which have a toxicity risk.

The panel also recommended that the FDA OK expanded use of Pfizer’s drug Fragmin to prevent a potentially fatal condition in cancer patients called venous thromboembolism, in which a blood clot forming in the legs makes its way to the lungs.