Among drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) in 2009-2013, efficacy was often confirmed in subsequent trials a minimum of 3 years after approval, and the use of nonrandomized studies and surrogate measures, instead of clinical outcomes, was common, according to a study published August 15th 2017 by JAMA. A… Continue reading Examining the Quality of Evidence for Drugs Granted Accelerated FDA Approval
Tag: accelerated approval process
Getting Potentially Life-Saving Drugs to High-Risk Breast Cancer Patients Faster
By Tatiana Prowell, M.D. and Richard Pazdur, M.D. Researchers at an international oncology conference held in October in Spain reported that pertuzumab, which was FDA-approved for treatment of HER2+ metastatic breast cancer in June 2012, improved survival by an average of nearly 16 months when added to standard treatment. This was yet another piece of… Continue reading Getting Potentially Life-Saving Drugs to High-Risk Breast Cancer Patients Faster