publication date: Feb. 6, 2015
FDA Grants Accelerated Approval To Ibrance in Breast Cancer
FDA granted accelerated approval to Ibrance (palbociclib) to treat metastatic breast cancer.
Ibrance inhibits cyclin-dependent kinases 4 and 6, which are involved in promoting the growth of cancer cells. Ibrance is intended for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole.
The FDA granted Ibrance a breakthrough therapy designation because the sponsor, Pfizer Inc., demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. It also received a priority review. Ibrance is being approved more than two months ahead of the prescription drug user fee goal date of April 13.
The drug’s efficacy was demonstrated in 165 postmenopausal women with ER-positive, HER2-negative advanced breast cancer who had not received previous treatment for advanced disease. Clinical study participants were randomly assigned to receive Ibrance in combination with letrozole or letrozole alone.
Participants treated with Ibrance plus letrozole lived about 20.2 months without their disease progressing (progression-free survival), compared to about 10.2 months seen in participants receiving only letrozole. Information on overall survival is not available at this time.
FDA approved the Koning Breast CT system and KBCT-guided biopsy bracket. KBCT is intended to provide three-dimensional images for diagnostic imaging of the breast.
KBCT, developed by the Koning Corporation, is the first commercially available 3D breast CT scanner designed to image the entire breast with a single scan without compression of the breast tissue. The system acquires hundreds of images in 10 seconds. The biopsy bracket … Continue reading 41-05 FDA Grants Accelerated Approval To Ibrance in Breast Cancer
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