publication date: Feb. 12, 2021

Come back later: ODAC rejects accelerated approval of neoadjuvant Keytruda in TNBC

By Paul Goldberg

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.

“I think that most of us believe that this trial may well turn out to be positive as time goes on with further analysis,” Hoffman said. “And as we see what the effect of the pathologic CR rate does in fact lead to, but I think there certainly is consensus among the committee that that hasn’t yet been demonstrated sufficiently to warrant going ahead with full approval right now, in our view, with regards to the risks that … Continue reading Come back later: ODAC rejects accelerated approval of neoadjuvant Keytruda in TNBC

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