FDA Approves First Novel Drug Through Cancer Drug Review Pilot Project

FDA’s approval Friday (May 24) of a new drug to treat breast cancer marks the first novel drug that has moved through the agency’s Real-Time Oncology Review (RTOR) Pilot program . While originally intended for supplemental applications of already-approved drugs, the ROTR, along with FDA’s Assessment Aid template, helped streamline review of the new drug without compromising the quality of FDA’s assessment, FDA’s cancer center director said. The approval of the drug, which was granted priority review designation, came three...