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EAST HANOVER, NJ-Novartis has submitted a supplemental new drug application (sNDA) to the FDA seeking approval for Gleevec (imatinib mesylate) for the treatment of patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GISTs). Last May, Gleevec received FDA approval for the treatment of patients with chronic myeloid leukemia in the blast crisis, accelerated phase, or in chronic phase after failure of interferon-alfa.

WASHINGTON-The National Cancer Institute will expand its support for trials of imatinib mesylate (Gleevec, also known as STI-571), recently approved for use in chronic myeloid leukemia (CML), to explore the drug’s potential in several other types of malignancies, director Richard D. Klausner, MD, told the National Cancer Advisory Board (NCAB).

n WHITE PLAINS, NY-The Leukemia & Lymphoma Society has joined in a collaborative partnership with Novartis to educate the public about imatinib mesylate (Gleevec, also known as STI-571), Novartis’ new oral medication approved by the FDA for patients with Philadelphia-chromosome-positive chronic myelogenous leukemia (CML) who have failed interferon therapy.

SOUTH SAN FRANCISCO-The FDA has approved a supplemental biological license application (sBLA) for Rituxan (rituximab), the monoclonal antibody developed by Genentech, Inc. and IDEC Pharmaceuticals (San Diego) for treatment of patient with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). The new product labeling includes re-treatment with rituximab after a prior course, initial treatment with eight weekly infusions instead of four, and treatment of bulky disease.

WASHINGTON-A new evaluation of existing scientific studies has found "limited or suggestive" evidence to link servicemen’s wartime exposures to herbicides in Vietnam with the development of acute myelogenous leukemia (AML) in their children. However, the Institute of Medicine (IOM) committee that reported the finding emphasized that the evidence for the association is not conclusive.

WASHINGTON -The Food and Drug Administration, acting with dispatch, has approved the marketing of Gleevec (imatinib mesylate, Novartis) for the treatment of chronic myeloid leukemia (CML). The agency granted the drug priority review and orphan drug status, and approved it under the FDA’s "accelerated approval" regulations less than 3 months after the sponsor submitted its marketing request.

Novartis recently announced that the United States Food and Drug Administration (FDA) approved its signal transduction inhibitor Gleevec (imatinib mesylate) as an oral therapy for the treatment of patients with chronic myeloid leukemia (CML) in

HOUSTON-Liposomal encapsulated tretinoin (Atragen) is active in relapsed aggressive T-cell and B-cell non-Hodgkin’s lymphomas (NHL) as well as in cutaneous T-cell lymphomas (CTCL), and strikingly effective in patients with primary refractory disease. Andreas H. Sarris, MD, PhD, associate internist and associate professor of medicine at the University of Texas M. D. Anderson Cancer Center in Houston, reported these results in a poster presentation. Liposomal tretinoin is more active than the oral formulation when tested against lymphoma cell lines and also down regulates expression of bcl-2, Dr. Sarris said.

NEW YORK-The promise of molecularly targeted therapies has been validated in chronic myelogenous leukemia (CML), Brian J. Druker, MD, of Oregon Health Sciences University, Portland, said at the Chemotherapy Foundation Symposium XVIII. "This disease has provided an ideal opportunity to test the concept that drugs targeted against a tumor-specific abnormality will have therapeutic utility," he said.

SAN FRANCISCO-Patients receiving monoclonal antibody-targeted chemotherapy with gemtuzumab ozo-gamicin (Mylotarg) rather than conventional combination chemotherapy for first relapse of acute myelogenous leukemia (AML) are more likely to be treated as outpatients, resulting in considerable cost savings, according to a study from Fred Hutchinson Cancer Research Center and Wyeth-Ayerst Research.

SAN FRANCISCO-Results of a phase II, open-label, multicenter study show that the investigational agent STI571 holds promise for many patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) whose disease has proved resistant to interferon therapy.

ASCO-STI-571, an investigational drug that has high activity in benign-phase chronic myelogenous leukemia (CML), also produces significant hematologic responses in patients with advanced-stage CML or acute forms of leukemia, Moshe Talpaz, MD, said at the 36th annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans.

ASCO-Mylotarg (gemtuzumab ozogamicin) has received FDA approval for treatment of CD33-positive acute myelogenous leukemia (AML) in patients age 60 and older in first relapse who are poor candidates for cytotoxic therapy. The agent, manufactured by Wyeth-Ayerst, was approved as an orphan drug.