More Than 1/4 of FDA’s 2015 Drug Approvals for Targeted Therapies

By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies

More than 28 percent of the novel new drugs approved by U.S. Food and Drug Administration (FDA) in 2015 were targeted therapies, according to the Personalized Medicine Coalition’s 2015 Progress Report: Personalized Medicine at the FDA. This is the second consecutive year that there has been an increased rate of personalized medicine approvals, the group says.

“This is more than a passing trend,” says Daryl Pritchard, Ph.D., vice president of the Personalized Medicine Coalition (PMC), in a statement. “The high proportion of new approvals that are personalized medicines demonstrates the progress researchers have made in advancing the field from an emerging idea a decade ago to an established approach to treating many diseases today.”

The FDA’s Center for Drug Evaluation and Research approved 45 novel new drugs (NNDs), either new molecular entities or new therapeutic biologics, last year. Of these approvals, 13 were classified by the PMC as personalized medicines, whose label includes reference to specific biological markers, identified through testing, to help guide clinical decisions.

Of the 13 approved personalized medicines five were oncology drugs. In addition to these five NNDs, the FDA expanded indications for four previously approved personalized medicine drugs to new molecularly defined subsets of patients. PMC also reports that the FDA approved three new drugs for treatment of rare genetic disorders.

While optimistic about the growth in FDA approvals for targeted therapies, PMC acknowledges that to more thoroughly integrate personalized medicine-related diagnostics into clinical practice, challenges related to diagnostic regulatory and reimbursement policy will need to be addressed.