Advocacy group unveils breakthrough diagnostics pathway

Friends of Cancer Research (FOCR) released on Friday a proposal to expedite the development of companion diagnostics intended for use with a drug that FDA has designated as a breakthrough therapy. The not-for-profit advocacy group said an expedited process is needed to ensure that development and approval of companion diagnostics does not lag behind and delay approval of breakthrough therapies. Under the proposal, FDA would use a risk-based approach to streamline the standard PMA process, for example by deferring some analytical and quality requirements to the post-market period.

Three-quarters of the applications FDA has accepted for the breakthrough therapies program include companion diagnostics, Mike Pacanowski, associate director for genomics and targeted therapy in CDER's Office of Clinical Pharmacology, said Friday at a meeting sponsored by Friends of Cancer Research. Because of this, "there is pressing need to clarify the pathways to make both products come to market in a timely fashion," Pacanowski said. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said it "will consider folding in the FOCR white paper" into the center's policy on pre- and postmarket data requirements to accelerate device development. ...