主页 > 生命科学 >

【drug-news】FDA批准Treanda(苯达莫司汀)用于慢性淋

FDA Approves Treanda for Patients With CLL

The following is a message from the FDA's Office of Oncology Drug Products Director, Dr. Richard Pazdur:
On March 20, 2008, the U.S. Food and Drug Administration (FDA) approved bendamustine hydrochloride (Treanda®, Cephalon, Inc.), an intravenously administered alkylating agent, for the treatment of patients with chronic lymphocytic leukemia (CLL).

The safety and efficacy of bendamustine were evaluated in a randomized, controlled, multicenter trial comparing bendamustine to chlorambucil as first-line treatment for CLL patients. The trial was conducted in 301 patients (153 on bendamustine and 148 on chlorambucil) with Binet Stage B or C (Rai Stages I - IV) CLL requiring treatment. Need-to-treat criteria included hematopoietic insufficiency, B-symptoms, rapidly progressive disease, or risk of complications from bulky lymphadenopathy. Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia, Richter's syndrome, or transformation to prolymphocytic leukemia were excluded. Patients were randomized to receive either bendamustine, 100 mg/m2 intravenously on days one and two every 28 days, or to receive chlorambucil, 0.8 mg/kg/day orally on days one and 15 every 28 days. Up to six cycles were administered to each patient.

The efficacy analyses were based on National Cancer Institute-Sponsored Working Group criteria. The overall response rate was 59 percent for bendamustine versus 26 percent for chlorambucil (p<0.0001) with 8 percent versus <1 percent complete responses on the bendamustine and chlorambucil arms, respectively. The median progression-free survival was 18 months for bendamustine versus six months for chlorambucil (hazard ratio 0.27, 95 percent CI 0.17, 0.43; p<0.0001). Survival data are not mature.

Patients treated with bendamustine had a higher incidence of adverse reactions (89 percent) than those treated with chlorambucil (79 percent). The most common adverse reactions (frequency > 15 percent) were neutropenia, pyrexia, thrombocytopenia, nausea, anemia, leucopenia, and vomiting. Neutropenic fever was more common in the bendamustine group compared to the chlorambucil group. Red blood cell transfusions were administered to 20 percent of the bendamustine-treated patients compared to six percent of those receiving chlorambucil. The most frequent adverse reactions leading to study withdrawal for patients receiving bendamustine were hypersensitivity and pyrexia. The number of deaths during the treatment period was similar in both treatment arms.

阅读本文的人还阅读:

【drug-news】FDA批准可直接

【科普】氢气对慢性肾脏

【medical-news】IDEAL新提示

中科院专家提出临床治疗

【文摘发布】分子印迹聚

作者:admin@医学,生命科学    2010-12-25 05:11
医学,生命科学网