Mylotarg: antibody-targeted chemotherapy comes of age.
Mylotarg (gemtuzumab ozogamicin, CMA-676; Wyeth-Ayerst Laboratories, Philadelphia, PA) recently was approved by the US Food and Drug Administration for the treatment of patients with CD33-positive acute myeloid leukemia in first relapse, age 60 years or older, who are not considered candidates for other types of cytotoxic chemotherapy. In combined phase II studies of 142 patients with CD33-positive acute myeloid leukemia in first relapse, Mylotarg monotherapy was associated with a 30% overall response rate. Although treated patients had relatively high incidences of myelosuppression, hyperbilirubinemia, and elevated hepatic transaminases, the incidences of severe mucositis and infections were low compared with what might be expected in association with conventional chemotherapeutic treatment. Preliminary data in pediatric patients also suggest that the immunoconjugate is reasonably well tolerated. Studies of Mylotarg in combination with anthracycline, cytarabine, and agents that inhibit P-glycoprotein are underway.
Sievers
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Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, USA. esievers@fhcrc.org
Linenberger
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D000368:Aged; D000410:Alanine Transaminase / Q000096:biosynthesis; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000494:pharmacology*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology*; D015703:Antigens, CD / Q000032:analysis; D015214:Antigens, Differentiation, Myelomonocytic / Q000032:analysis; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology*; D001219:Aspartate Aminotransferases / Q000096:biosynthesis; D002986:Clinical Trials as Topic; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000276:immunology; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D018579:Patient Selection; D063268:Sialic Acid Binding Ig-like Lectin 3; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D015703:Antigens, CD; D015214:Antigens, Differentiation, Myelomonocytic; D000970:Antineoplastic Agents; C571163:CD33 protein, human; D063268:Sialic Acid Binding Ig-like Lectin 3; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase