Contact: Michael Blash, Zeneca Pharmaceuticals
Phone: 302-886-5465
Email: [email protected]
FOR IMMEDIATE RELEASE
UPDATED CASODEX LABELING INCLUDES DATA FROM MAJOR CLINICAL TRIAL CONFIRMING CLINICAL BENEFITS
WILMINGTON, Del. - January 26, 1998 - Updated labeling for CASODEX(R) (bicalutamide) tablets recently cleared by the Food and Drug Administration includes new survival data from one of the largest advanced prostate cancer research studies ever conducted. The new information confirms the previously shown clinical benefits and safety of CASODEX, which is the most prescribed antiandrogen in the United States. The study, a double-blind, randomized controlled clinical trial conducted throughout North America and published in the clinical journal Urology (1) compared CASODEX with another agent, flutamide(2), each given in combination with a luteinizing hormone-releasing hormone agonist (LHRH-A) in 813 patients with advanced prostate cancer. The study showed that CASODEX plus LHRH-A was generally well tolerated and demonstrated no significant difference in time to progression and survival compared to flutamide plus LHRH-A. In an analysis conducted after a median follow-up of 160 weeks was reached, 52.7% (213) patients treated with CASODEX-LHRH-A therapy and 57.5% (235) patients treated with flutamide-LHRH-A therapy had died. There was no significant difference in survival between these treatment groups. There was also no significant difference in time to objective tumor progression between these treatment groups. "The new label information confirms the previously shown clinical benefits of CASODEX," said Geert Kolvenbag, MD, Senior Medical Director for Zeneca Pharmaceuticals. "Also, the one tablet, once-daily dosing regimen of CASODEX adds to patient convenience." æmoreæ
UPDATED CASODEX LABELINGÖ/page 2 of 2
CASODEX, developed by Zeneca Pharmaceuticals, received FDA clearance in October 1995 for use in combination therapy with an LHRH-A for treatment of advanced (stage D2) metastatic prostate cancer. CASODEX is given with an LHRH-A such as ZOLADEX(R) (goserelin acetate implant) as part of a treatment regimen called Combined Androgen Blockade (CAB). The goals of CAB are to reduce production of the male hormone testosterone and to block stimulation of prostate cancer cells by any remaining testosterone. The most commonly reported adverse events with CASODEX plus LHRH-A are hot flashes, pain, constipation, back pain, pelvic pain, nausea, diarrhea, and infection. According to the American Cancer Society, in 1998 more than 189,500 men in the United States will be diagnosed with prostate cancer this year, with 39,200 deaths resulting from the disease. In fact, prostate cancer is the most frequently diagnosed of all malignancies in men--other than certain skin cancers--and is second only to lung cancer as a cause of cancer-related deaths in males. Zeneca Pharmaceuticals is a business unit of Zeneca Inc., based in Wilmington, Del. In the United States, Zeneca Inc. is a $3.1 billion bioscience company with 7,200 employees. Zeneca Inc. is a wholly-owned subsidiary of the U.K.-based Zeneca Group PLC (NYSE:ZEN), a major $9 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services. # # #
Schellhammer P, Sharifi R, Block N, et al. Clinical benefits of bicalutamide compared with flutamide in combined androgen blockage for patients with advanced prostatic carcinoma: Final report of a double-blind randomized multicenter trial. Urology 1997; 50 (3): 330-336.
Flutamide (Eulexin(R)), Schering-Plough
RSS