Targeted drug therapy remains a challenge

Abstract

Personalized drug therapy is starting to become a reality, but no one knows when the technology will become widespread in clinical practice, FDA’s Janet Woodcock said during an October conference hosted by the agency and the Drug Information Association. “FDA has been advocating for tailored therapeutics for over a decade,” said Woodcock, the director of FDA’s Drug Evaluation and Research Center. “We’re now out of the phase of general skepticism [and] into the long slog phase,” she said. “I believe we’ll get there. It’s just a matter of when.” Woodcock said that FDA in August approved two tailored therapeutics for the treatment of cancer: Pfizer’s kinase inhibitor crizotinib and Genentech’s vemurafenib. Each drug was approved alongside a diagnostic genetic test to identify patients whose tumor cells are likely to respond to the therapy. According to FDA, the approval of therapeutic drugs whose effectiveness or safety depends on the use of a diagnostic test for a biomarker is becoming increasingly common. FDA issued a draft guidance document this past summer to help manufacturers understand the agency’s expectations for moving such products and their companion diagnostics through the regulatory process.