BioCentury
ARTICLE | Regulation

Survival projections aren’t enough to sway ODAC to recommend Keytruda for new TNBC indications

February 9, 2021 11:59 PM UTC

FDA and its Oncology Drugs Advisory Committee want more survival data before supporting an accelerated approval of Keytruda as an adjuvant and neoadjuvant therapy for triple-negative breast cancer — a decision that could set precedent as immunotherapies continue their march into earlier lines of treatment. 

The committee and regulators agreed that predictive probability modeling for survival benefit isn’t an appropriate surrogate for actual survival data in the adjuvant setting...