Review and approval of oncology and hematology drugs at FDA from 2005 to 2007

Jan 29, 2010

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 reviewed, of which 53 were approved, according to 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 Drug Products in the Center for and Research, Rajeshwari Sridhara, Ph.D., of the FDA's Office of Biostatistics, in Silver Spring, Md., and colleagues identified all applications reviewed, 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 reviewed and regulatory action was taken on 58 of them based on a risk-benefit evaluation. Products that demonstrated efficacy and had an acceptable risk-benefit ratio (i.e., the magnitude of the treatment 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 Two applications were withdrawn before action was taken, and five were not approved.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.

Explore further: Study finds information lacking from FDA on implanted medical devices

More information: jnci.oxfordjournals.org

add to favorites email to friend print save as pdf

Related Stories

FDA acts against unapproved colchicine

Feb 06, 2008

The U.S. Food and Drug Administration said it will take action against companies marketing unapproved injectable colchicine, a drug used to treat gout.

Generic pediatric AIDS Drug gets U.S. OK

Jun 28, 2006

The U.S. Food and Drug Administration has tentatively approved the generic version of Abacavir Sulfate Oral Solution for use by pediatric AIDS victims.

FDA OKs Amitiza for treatment of IBS-C

Apr 30, 2008

The U.S. Food and Drug Administration announced approval of Amitiza (lubiprostone) to treat constipation associated with irritable bowel syndrome.

Recommended for you

Viagra ads target women for first time

15 hours ago

The maker of the world's top-selling erectile dysfunction drug on Tuesday will begin airing the first Viagra TV commercial in America that targets the less-obvious sufferers of the sexual condition: women.

User comments : 0