New indication for drug for breast cancer patients
The Food and Drug Administration has given Pfizer Inc. the green light to market Aromasin (exemestane tablets) for adjuvant treatment of postmenopausal women with estrogen receptor-positive early breast cancer, according to the company. The approval would allow these women to switch to Aromasin after taking tamoxifen for only 2 to 3 years rather than waiting a full 5 years to do so. The federal agency based its approval on the Intergroup Exemestane Study (IES)-reported in The New England Journal of Medicine-which found that patients who switched to Aromasin after 2 to 3 years of tamoxifen for a combined total of 5 years of therapy, had 31% more protection from cancer recurrence than those who stayed on tamoxifen for 5 years. The American Society of Clinical Oncology and the National Comprehensive Cancer Network have since updated their guidelines to support the switch, Pfizer said. The IES trial involved more than 4,700 postmenopausal women with estrogen receptor-positive breast cancer who were followed for 35 months on average.
The drug's common side effects include mild-to-moderate hot flashes (21.2%), fatigue (16.1%), and arthralgia/bone pain (14.6%). For more information, visit the company's Web Site at http:// http://www.pfizer.com/.
For more information and full prescribing information, visit the company Web site at http:// http://www.berlex.com/.
Upgraded cystic fibrosis assay tests for 97 mutations
In May 2005, the FDA approved the first DNA-based blood test to help detect cystic fibrosis, Tm Bioscience Corporation's (Toronto, Canada) Tag-It Cystic Fibrosis Kit. It was the first multiplexed human disease genotyping test to be cleared by the federal agency for use in the United States. Recently, the company announced that Genzyme Genetics has launched its upgraded CFplus cystic fibrosis mutation analysis, which now includes testing for 97 mutations. For more information, visit the Tm Bioscience Web site at http:// http://www.tmbioscience.com/.
High-quality U/S in a laptop-sized package
For more information, visit the company's Web site at http:// http://www.sonosite.com/.