The US Food and Drug Administrations
(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 FDAs 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.