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Approval of Antibody-Targeted Chemotherapy Recommended

May 1, 2000
Publication
Article
OncologyONCOLOGY Vol 14 No 5
Volume 14
Issue 5

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

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.

Articles in this issue

Medicare Rethinking Its Policy on Self-Injectables
Home Counseling Program for Women With Lung Cancer to Be Studied
New Indication Sought for Bicalutamide
Approval of Antibody-Targeted Chemotherapy Recommended
NIH Consensus Development Conference on Adjuvant Therapy for Breast Cancer Planned
First Comparison of Anastrozole vs Tamoxifen
Prolonged Androgen Blockade May Boost Survival in Advanced Prostate Cancer
FDA Approves Irinotecan as First-Line Therapy for Colorectal Cancer
Understanding Leukaemia and Related Cancers
Bill Will Allow Doctors to Negotiate Jointly With HMOs
New Drug for Refractory Cutaneous T-Cell Lymphoma
New Clinical Trials Data Bank
Exisulind Shows Positive Results in the Prevention of Precancerous Colon Polyps
Commentary (Hewitt): An Alternative Algorithm for Dosing Transdermal Fentanyl for Cancer-Related Pain
Commentary (Carr/Goudas): An Alternative Algorithm for Dosing Transdermal Fentanyl for Cancer-Related Pain
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