FDA’s oncology advisory committee voted 6-3 Thursday against AstraZeneca’s late-stage trial for an oral drug candidate, voting down what the company had called a new paradigm in the field.
Three panel members sided with AstraZeneca. Six didn’t. The committee’s meeting Thursday was its first in about nine months.
FDA advisory panels aren’t the final word, but FDA follows panel recommendations roughly 75% of the time. A split of 6-3 against a sponsor is a clear result. AstraZeneca’s position after Thursday is weaker than before.
The new paradigm framing tells you what was really at stake. AstraZeneca wasn’t just seeking a green light for one drug. It was asking the panel to accept a different way of thinking about this type of trial. The committee said that case wasn’t made.
AstraZeneca now faces a response process with FDA. The company must file a formal response before the agency issues its final ruling.
— Sarah Chen