OncLive Nursing FDA Updates From April 2011
3D mammogram system approved, NCCN 2011 Avastin breast cancer guidelines, and the approval of generic docetaxel.
3D Mammography System Approved
The first x-ray mammography device that provides 3-dimensional (3D) images of the breast has gained FDA approval. The agency said the Selenia Dimensions System, which uses the process of tomosynthesis, might help physicians more accurately detect and diagnose breast cancer. Currently, about 10% of women screened with conventional 2-dimensional (2D) mammography undergo further testing for abnormalities that prove to be benign, the FDA said. For further information, go to http://tiny.cc/7ok9f .
NCCN 2011 Guidelines for Breast Cancer Continue to Recommend Avastin
The NCCN’s 2011 Guidelines for Breast Cancer recommend Avastin (bevacizumab) in metastatic breast cancer, despite the FDA’s move toward revoking the indication. The NCCN continues to back Avastin based on the PFS benefit demonstrated in several trials. The same trials failed to show an overall survival benefit with Avastin, and an FDA panel concluded Avastin’s side effect risks outweigh its PFS benefit. The FDA granted Avastin manufacturer Genentech a hearing to plead its case against revocation on June 28 and 29.
Generic Docetaxel Approved
The FDA has authorized pharmaceutical company Hospira Inc to market generic docetaxel. It is the first generic version of Taxotere sold in the United States. Taxotere’s patent expired in November 2010, but the FDA had requested that Hospira make alterations to its generic drug’s label before distribution. Docetaxel is FDA-approved for the treatment of breast, non— small cell lung, prostate, gastric, and head and neck cancers.