The approval is based on phase-3 data reported one year ago, in which Breyanzi showed statsig-superior EFS compared to SoC (#msg-164317285).
Breyanzi will compete in this newly approved indication with GILD’s Yescarta (#msg-167110232).
Breyanzi was initially FDA-approved for third-line LBCL in Feb 2021 (#msg-161552697). This is the drug at the heart of the lawsuit by former CELG shareholders (#msg-169238809).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”