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On August 22, 2008, the US Food and Drug Administration (FDA) granted marketing approval (licensure) to romiplostim (Nplate, Amgen Inc) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

A triple therapy with fludarabine, cyclophosphamide, and rituximab (Rituxan) was hailed as the new standard of care for chronic lymphocytic leukemia at ASH 2008 in San Francisco. Now a new study has deemed low-dose fludarabine and cyclophosphamide combined with high-dose rituximab (FCR-Lite) as highly effective in untreated CLL patients.

SAN FRANCISCO-While genetics has opened up new possibilities for predicting treatment response in patients with acute myeloid leukemia, there are still unanswered questions about the relationship between genetic mutations and treatment outcome, according to Bob Lowenberg, MD, PhD, who delivered the Ham-Wasserman lecture at ASH 200

Cephalon, Inc, announced that the US Food and Drug Administration (FDA) has approved injectable bendamustine hydrochloride (Treanda) for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab (Rituxan) or a rituximab-containing regimen. The data supporting the FDA approval show that bendamustine is effective, has a tolerable side effect profile in patients with indolent NHL, and that treatment results in a high durable response rate. In March of this year, bendamustine received approval for the treatment of patients with chronic lymphocytic leukemia, the most common form of leukemia in the United States.

Results from the multinational randomized phase III REACH trial demonstrate that the combination known as FCR (fludarabine, cyclophosphamide, rituximab [Rituxan]) provides a 10-month improvement in progression-free survival, compared with fludarabine/cyclophosphamide (FC) alone, and a near doubling of complete response rates in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The study results were presented by lead investigator Tadeusz Robak, md, of the Medical University of Lodz in Poland, at the 50th Annual Meeting of the American Society of Hematology (ASH), held Dec 6–9 in San Francisco (abstract LBA-1).

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).