USA – FDA gives Project Renewal update at AACR

Generic cytotoxic cancer drugs are a cornerstone of cancer therapy, but their labels may not reflect current best evidence regarding safety and effectiveness. Progress on a pilot FDA effort to modernize labels for these drug was shared by Patricia Keegan, MD, acting associate director for medical policy at the FDA’s Oncology Center of Excellence, at the virtual annual meeting of the American Association for Cancer Research.

Project Renewal, begun at the end of 2018, had a goal of updating generic chemotherapy labels still in clinical use but without brand name reference products. At the time Project Renewal was kicked off, officials planned and later held six workshops to define the scope of the project and to develop procedures.

Currently, the pilot project to update labeling for cancer drugs approved prior to 2006 is evaluating fluorouracil, cisplatin, capecitabine and daunorubicin. The goal is to update labeling information “by evaluating relevant scientific evidence from the published literature,” said Keegan. To aid in this effort, FDA has tapped participants in Project Socrates, which engages medical oncology, hematology, radiation oncology and pediatric oncology fellows for 1-2 month stints at FDA, where they learn about FDA’s role in drug approval.

In giving some background to the project, Keegan reviewed recent history of FDA labeling regulations. FDA, she said, had always had an expectation that labeling content would be updated over time by manufacturers, as required by FDA’s Physician Labeling Rule (PLR). “Unfortunately, » she said, « the expectation that labeling would be updated by drug manufacturers with current information was frequently not met.”…