1/ I was on the @FDAOncology ODAC for sotorasib, a KRAS G12Ci tested in NSCLC. We voted no, almost unanimously. A year later adagrasib + cetuximab got accelerated approval (AA) for colorectal cancer based on KRYSTAL-1.
KRYSTAL-10 was a phase 3 RCT testing that combo and just reported negative findings. Last week adagrasib came off the market.
I've already seen this called a failure of accelerated approval (AA). I'd argue the opposite.