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PROPEL, a multicenter phase II open-label study-the largest prospective clinical trial in patients with relapsed or refractory peripheral T-cell lymphoma-found that the investigational chemotherapy agent pralatrexate produces complete responses (disappearance of all signs of cancer) in patients who had previously failed an average of three treatment regimens, including an autologous stem cell transplant for some patients. Designed to be selectively transported into tumor cells, the novel antifolate pralatrexate accumulates to high concentrations in the tumor cell, inhibiting DNA synthesis, said Owen A. O’Connor, md, phd, Columbia University Medical Center, New York, at the ASH meeting (abstract 261).

Burkitt lymphoma (BL) is a unique B-cell lymphoma characterized by a high proliferation rate and cytogenetic changes related to c-myc proto-oncogene overexpression. Burkitt lymphoma is a highly aggressive B-cell lymphoma that is most frequently seen in children and young adults in endemic areas.

Eisai Corporation of North America announced that the US Food and Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for denileukin diftitox (Ontak) solution for intravenous injection for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+).

WOODCLIFF LAKE, New Jersey-Eisai Corporation of North America has announced that FDA has accepted for priority review a supplemental biologics license application for the company’s fusion toxin protein Ontak (denileukin diftitox).

Eisai Corporation of North America announced today that the US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for denileukin diftitox (Ontak). The sBLA seeks to convert an accelerated approval indication into full approval. It is based on a placebo-controlled phase III clinical trial to confirm the clinical effectiveness of the drug in certain patients with cutaneous T-cell lymphoma (CTCL).

Chronic myelogeneous leukemia (CML) is a biologically unique neoplasm resulting from a mutation producing a single abnormal protein that induces unregulated proliferation of myelopoiesis. Imatinib mesylate (Gleevec) profoundly inhibits the chimeric bcr/abl tyrosine kinase, and has dramatically improved the outlook for patients with CML in chronic phase.

The management of patients with chronic myelogenous leukemia (CML) has been altered dramatically since the introduction of tyrosine kinase inhibitors by Druker et al in the late 1990s.

Long-term results of a German randomized trial suggest that a novel escalated-dose regimen may replace the current chemotherapy standard of care for treatment of advanced-stage Hodgkin lymphoma. Volker Diehl, MD, of the University of Cologne, Germany, presented 10-year follow-up data on behalf of the German Hodgkin Study Group at ASH 2007 (abstract 211).

Among Ph+ chronic myelogenous leukemia patients in accelerated phase with imatinib (Gleevec) resistance or intolerance, treatment with nilotinib (Tasigna) rapidly produced significant responses and was generally well tolerated in an open-label pivotal phase II study

Study results presented at ASH 2007 showed efficacy of the novel tyrosine kinase inhibitor dasatinib (Sprycel) in imatinib (Gleevec) resistant or intolerant chronic myelogenous leukemia patients in chronic, accelerated, and blast phase

In a significant proportion of imatinib (Gleevec)-resistant chronic-phase chronic myelogenous leukemia patients with Bcr-Abl mutations, nilotinib (Tasigna) treatment results in hematologic, cytogenetic, and molecular responses