Oncologic Drugs Advisory Committee (ODAC) panel members recommended that Abraxis and the FDA work together to identify selected patient populations for a “reasonably sized” randomized trial to confirm safety and efficacy of Abraxane leading to approval as adjuvant treatment.
Commenting on the recommendations, Dr Michael Hawkins, chief medical officer of Abraxis, said: “We are encouraged by the ODAC panel’s recommendation and we intend to move as quickly as possible to discuss the next steps with the FDA. If the FDA agrees with today’s recommendation by the committee, this may enable approval in this indication earlier than typically expected.”
Abraxane is currently approved in the US for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
Abraxane is the first in a new class of protein-bound taxanes that takes advantage of albumin, a human protein and natural carrier of water insoluble molecules. The active agent in Abraxane is paclitaxel, a naturally derived product with anti-tumor activity. The use of albumin eliminates the need for solvents and the associated toxicities with solvent-based paclitaxel chemotherapy.