Antibody-Targeted Chemotherapy Included in NCCN Oncology Practice Guidelines

March 1, 2002

Wyeth-Ayerst Laboratories announced recently that thousands of patients affected by acute myeloid leukemia (AML) may benefit from the new National Comprehensive Cancer Network (NCCN) guidelines for the appropriate treatment of AML, including the use of gemtuzumab ozogamicin (Mylotarg) in specific clinical situations. The only antibody-targeted chemotherapeutic agent approved by the US Food and Drug Administration, gemtuzumab is indicated for patients with CD33-positive AML in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. The safety and efficacy of this agent in patients with poor performance status and organ dysfunction has not been established.

Wyeth-Ayerst Laboratories announcedrecently that thousands of patients affected by acute myeloid leukemia (AML) maybenefit from the new National Comprehensive Cancer Network (NCCN) guidelines forthe appropriate treatment of AML, including the use of gemtuzumab ozogamicin (Mylotarg)in specific clinical situations. The only antibody-targeted chemotherapeuticagent approved by the US Food and Drug Administration, gemtuzumab is indicatedfor patients with CD33-positive AML in first relapse who are 60 years ofage or older and who are not considered candidates for other cytotoxicchemotherapy. The safety and efficacy of this agent in patients with poorperformance status and organ dysfunction has not been established.

"We are pleased about the inclusion of Mylotarg in the NCCNguidelines because it shows that this innovative technology is having an impactin real clinical practice," said Harold K. Marder, md, senior vicepresident of Global Medical Affairs, Wyeth-Ayerst Laboratories. "Targetedtherapies are an important component of the future of cancer treatment, andWyeth is committed to researching and developing drugs like Mylotarg thatprovide effective, tolerable treatments for patients with deadly cancers."

Guidelines Updated Annually

Founded in 1995, the NCCN is dedicated to advancing the missionof its member institutions in education, research, and patient care. Theorganization’s annually updated practice guidelines are recognized as thestandard for clinical policy in oncology.

"We provide the entire professional oncology community withtreatment recommendations based on the experience of our memberinstitutions," said William T. McGivney, phd, CEO of the NCCN. "Thelandscape of cancer treatment is constantly changing, and we are committed tokeeping oncologists on the cutting edge."

The NCCN AML Guidelines are available through the NCCN. For moreinformation, call the NCCN at (215) 728-4788 or contact them at www.NCCN.org.