In a unanimous vote, the FDA Oncologic Drugs Advisory Committee recommended against an accelerated approval for Keytruda for patients with high-risk, early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery.
The company was seeking approval based on the surrogate endpoint of pathologic complete response.
The advisory committee’s recommendation—reached in a 10:0 vote with no abstentions at the Feb. 9 meeting—was to defer any approval decision until more mature data from the company’s ongoing clinical trial are available.
In an odd regulatory/linguistic twist, a Yes vote indicating “Yes, defer,” amounted to a “No, do not approve.”
“In the couple of years that I’ve been on the ODAC, this is the first time that I’ve encountered a voting question that basically said, should we defer this, as opposed to the Yes or No. Has the efficacy and safety been demonstrated, so Yes or No, we should approve,” ODAC Chair Philip C. Hoffman, professor of medicine at the University of Chicago Section of Hematology/Oncology Department of Medicine, said after the votes were cast.
