Approval of Antibody-Targeted Chemotherapy Recommended

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recently voted to support approval of gemtuzumab ozogamicin (Mylotarg) for the treatment of patients ³ 60 years old with CD33-positive, relapsed, acute myeloid leukemia (AML). If approved by the FDA, gemtuzumab ozogamicin would be the first chemotherapeutic agent targeted directly to cancerous cells using monoclonal antibody technology. Currently, there are no medications approved for the treatment of relapsed AML patients.

New Class of Anticancer Therapy

Gemtuzumab ozogamicin is the first in a new class of anticancer therapy called antibody-targeted chemotherapy. This chemotherapy is based on a novel technology that uses a proprietary “linker” to combine a potent antitumor antibiotic with an anti-CD33 antibody. Gemtuzumab ozogamicin is linked with the antitumor antibiotic, calichea-micin. The antibody portion binds specifically to the CD33 antigen expressed by myeloid leukemic cells.

“This favorable recommendation from the FDA’s Advisory Committee brings antibody-targeted chemotherapy one step closer to older Americans with CD33-positive relapsed AML,” said Patrick Gage, president, Wyeth-Ayerst Research. “When this breakthrough technology platform is applied to other monoclonal antibodies, we have the potential to develop treatments for other types of human cancer.”

Gemtuzumab ozogamicin was developed jointly by Wyeth-Ayerst and Celltech Group and, under the terms of a collaborative agreement, will be marketed by American Home Products.