Abstract
A collection of recently published news items.
The FDA launched a public dashboard to enable better access to reports of adverse drug reactions. The interactive web-based tool, available at www.fda.gov, is designed so that consumers can easily query the FDA's Adverse Event Reporting System using various criteria, including biological product and type of adverse event. The agency hopes the tool will spur the submission of more detailed safety reports.
Three Bristol-Myers Squibb trials evaluating nivolumab (Opdivo)-based combinations in multiple myeloma were placed on partial clinical hold by the FDA. The move came a week after the agency issued a safety alert on the use of certain pembrolizumab (Keytruda; Merck) combinations to treat the disease. For now, the FDA has determined that the risks of such combination therapies for multiple myeloma outweigh the potential benefit.
Eli Lilly announced plans to cut about 3,500 jobs globally, a move expected to yield annual savings of $500 million starting in 2018. The cuts translate to a workforce reduction of roughly 8% and will mainly come from a voluntary early-retirement program offered in the United States.
The FDA granted accelerated approval to copanlisib (Aliqopa; Bayer), which inhibits PI3Kα and PI3Kδ, for the treatment of follicular lymphoma, an indolent form of non–Hodgkin lymphoma with few therapeutic options. In a trial of 104 patients who had relapsed after at least two prior therapies, 59% had a complete or partial response to copanlisib for a median of 12.2 months.
Researchers pegged the cost of developing a single cancer drug in the United States at $648 million; median revenue for the 10 drugs considered in their analysis was calculated to be $1,658.4 million after a median of 4 years on the market (JAMA Intern Med 2017 Sep 11 [Epub ahead of print]). An earlier estimate put the cost of bringing a single drug to market at $2.7 billion, adjusted to 2017 dollars (J Health Econ 2016;47:20–33).
For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/content/early/by/section.