Changing End Points in Breast-Cancer Drug Approval - The Avastin Story.
Summary of "Changing End Points in Breast-Cancer Drug Approval - The Avastin Story."
In December 2007, the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) met to discuss the risks and benefits of Genentech's Avastin (bevacizumab) for use in combination with paclitaxel for first-line treatment of locally recurrent or metastatic HER2-negative breast cancer. In an unusual move, Genentech and the FDA proposed that the committee (on which I serve as a voting consultant) consider progression-free survival rather than overall survival as the primary end point. In the key study submitted, bevacizumab plus paclitaxel was statistically superior to paclitaxel alone in terms of progression-free survival but not overall survival. Surprisingly, . . .
Affiliation
From the Mathematics and Statistics Department, Boston University, Boston.
Journal Details
This article was published in the following journal.
Name: The New England journal of medicine
ISSN: 1533-4406
Pages: e2
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21707384
- DOI: http://dx.doi.org/10.1056/NEJMp1106984
Medical and Biotech [MESH] Definitions
Drug Approval
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.
Drug And Narcotic Control
Control of drug and narcotic use by international agreement, or by institutional systems for handling prescribed drugs. This includes regulations concerned with the manufacturing, dispensing, approval (DRUG APPROVAL), and marketing of drugs.
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
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