Approval of oncology drugs at FDA

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Over a two and half year period, beginning in 2005 when the U.S. Food and Drug Administration's oncology drug product's office began reviewing marketing applications, a total of 60 new oncology and hematology drugs were evaluated, of which 53 were approved, as per a new article published online January 29 in the Journal of the National Cancer Institute
To provide an overview of recent regulatory actions by the FDA's Office of Oncology Drug Products in the Center for Drug Assessment and Research, Rajeshwari Sridhara, Ph.D., of the FDA's Office of Biostatistics, in Silver Spring, Md., and his colleagues identified all applications evaluated, as well as actions taken, from July 1, 2005, through December 31, 2007. Their review included "New Drug Application" and "Biologics Licensing Application" approvals.

Marketing applications for 60 new products were evaluated and regulatory action was taken on 58 of them based on a riskbenefit assessment. Products that demonstrated efficacy and had an acceptable riskbenefit ratio (i.e., the magnitude of the therapy effect was statistically persuasive and clinically meaningful) were granted either regular or accelerated marketing approval. A total of 53 new indications were approved: 39 received regular approval, nine received accelerated approval, and five were converted from accelerated to regular approval. Two applications were withdrawn before action was taken, and five were not approved.

Approvals were based on various study designs and primary outcomes or endpoints. Some approvals were from single-arm, non-randomized controlled trials in cases when the FDA deemed it impractical to conduct randomized studies.


Posted by: Janet    Source