BMS, Novartis, Gilead, Iovance dinged over biologics promos in rare spate of CBER untitled letters

The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a rare spate of four untitled letters to Iovance Biotherapeutics, Bristol Myers Squibb, Novartis, and Gilead Sciences’ Kite Pharma. These letters cite “false or misleading” promotional materials for their respective biologics, specifically concerning references to “exploratory analyses” and unapproved efficacy data like overall survival and progression-free survival. The FDA expressed concern that these promotions could mislead doctors and patients about the treatments’ risks and benefits.