Fewer than half of postmarketing studies required for drugs granted accelerated approval (AA) have been completed . A study evaluated whether drugs that were granted accelerated approval (AA) fulfilled their postmarketing requirements (PMRs) during the past 6 years. The researchers reviewed the FDA’s published Novel New Drug Summaries between 2011 and 2016. The results found that 23 out 49 drugs that were approved received AA. Of these, 17 had PMRs, including 34 clinical trials, to complete. Only 15 (44%) have been completed, 14 (41%) are ongoing, 2 (6%) have been terminated, and 3 (9%) are pending. Of the 15 completed trials, 3 (20%) have failed, all of which were intended as confirmatory trials (for atezolizumab, nivolumab, and pembrolizumab). The researchers also identified 3 drugs that were granted AA but failed to meet their efficacy endpoints. None of these 3 drugs has been pulled from the market. Via JAMA Oncology. Published May 10, 2018.
A new study is suggesting that some cancer drugs that are deemed “breakthrough” therapies and granted quicker approval are not always safer or more effective than drugs without the designation. Researchers evaluated 58 new cancer treatments approved by the FDA between 2012 and 2017. Approximately 43% (25) were labeled as a breakthrough therapy. Those medications were approved in about 5 years compared to 7 years for standard drugs. Although the drugs were considered breakthroughs, the results of this study indicate otherwise. These medications “did not yield statistically significant differences in median gains in progress-free survival, the response rate of solid tumors to treatment, relying on a novel mechanism of action, or the subsequent rates of death or side effects,” according to the study. Via Journal of Clinical Oncology. Posted April 24, 2018.
Walmart will implement new policies and programs in the fight against the nation’s prescription opioid epidemic. One of the new initiatives introduced earlier this year is that the giant retailer will now offer a free opioid disposal solution, DisposeRx, in all pharmacies nationwide. Walmart and Sam’s Club will also be restricting opioid prescriptions to no more than a 7-day supply. Moreover, by 2020, Walmart and Sam’s Club will require e-prescriptions for opioids. Via Business Wire. Posted May 7, 2018.