Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals
Executive Summary
Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.
You may also be interested in...
US FDA Needs ‘More Clout’ To Get Supply Chain Information, Califf Says
‘It’s driving me crazy that supply chains are a trade secret,’ FDA commissioner states. Agency also needs more clout to handle accelerated approvals, he tells gathering of industry executives and government policy makers.
US FDA Needs ‘More Clout’ To Get Supply Chain Information, Califf Says
‘It’s driving me crazy that supply chains are a trade secret,’ FDA commissioner states. Agency also needs more clout to handle accelerated approvals, he tells gathering of industry executives and government policy makers.
Failed Confirmatory Trial Won’t Force Withdrawal Of Zepzelca’s Accelerated Approval, US FDA Says
Jazz/PharmaMar’s SCLC drug will stay on the market while two more trials with different designs are conducted after confirmatory trial did not meet overall survival endpoint. Citizen petition requesting agency withdraw lurbinectedin underscores vagaries of accelerated approval.