image credit: Adobe Stock

FDA panel finds KRAS drug data unreliable, in blow to Amgen

October 6, 2023


The negative panel vote is a setback in Amgen’s efforts to cement Lumakras’ U.S. approval, but doesn’t appear likely to result in the drug’s withdrawal from market.

Many of the advisers, in explaining their “no” votes, indicated they were ruling narrowly on the question of CodeBreak 200’s reliability, rather than delivering a verdict on Lumakras more broadly.

“I voted no, but it’s not a question about the drug or what I feel about the drug, or the importance that I think it offers my community of lung cancer patients and survivors,” said James Pantelas, the committee’s patient representative.

Read More on Biopharma Dive