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Cancer drug approvals evaluated by government


More than 50 new indications for oncology and hematology drugs and biologics were cleared by the FDA?s Office of Oncology Drug Products from 2005 to 2007.

More than 50 new indications for oncology and hematology drugs and biologics were cleared by FDA’s Office of Oncology Drug Products from 2005 to 2007. The retrospective analysis was published in the February 24, 2010, issue of the Journal of the National Cancer Institute.

FDA’s Office of Oncology Drug Products, part of the Center for Drug Evaluation and Research, acted on 58 applications, giving approval to 53 new cancer indications. Approvals represented indications for 18 new drugs, which were first-time approvals; 35 approved drugs were granted new indications.

In a statement, Richard Pazdur, MD, director of the Office of Oncology Drug Products, and a co-author of the analysis, said, “The FDA used a variety of trial designs and end points in approving these applications. In addition, we implemented recent regulatory initiatives including accelerated approval and priority reviews to expedite the approval of these indications.”

An additional finding from the cancer drug approvals analysis was that new treatments were cleared for 6 of the most fatal forms of cancer (lung, pancreatic, colon, cervical, breast, and ovarian). Advanced kidney cancer now has 3 new treatments. Nine drugs were part of the accelerated approval program.

“Whether it’s development of a new drug or novel use of an existing one, oncology research has been tremendously prolific in the last year, perhaps more so than any other subspecialty in the field of medicine,” said Monica Mehta, PharmD, assistant professor, Long Island University Arnold & Marie Schwartz College of Pharmacy and Health Sciences. “Healthcare professionals working in oncology will have plenty of additional homework in the coming months to stay abreast of the 50-plus new indications for cancer drugs, determine roles for new products on formularies, and shuffle older drugs to newer uses.

“Despite this downside, which is growth in complexity, most practitioners perceive these developments as a boon in a very challenging patient population,” Dr Mehta adds. “Over the next few years, it will be interesting to observe how this development boom will impact morbidity and mortality as well as life span and quality among oncology patients.”

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