Evaluate Vantage Report: US Approvals Under the Spotlight


On April 27-29, a three-day US advisory committee meeting convenes. Their objective is to scrutinise the accelerated approvals of certain anti-PD-(L)1 drugs whose confirmatory trials have failed. Will the US FDA's standards change after years of apparent leniency?

'US Approvals Under the Spotlight', the latest report from Evaluate Vantage, outlines the panel’s scope, details the specific drug uses being scrutinised and examines what could be at stake for the industry.

Download the report now for a historical perspective into evidence that the accelerated approval pathway has become increasingly popular over the past 11 years, as well as a look ahead that spotlights other drugs that remain conditionally approved with no confirmatory clinical evidence of benefit years after their regulatory green lights.

Report Contents:

  • Adcom scope and the case of Tecentriq
  • Other accelerated approval withdrawals
  • FDA reputation over 11 years of accelerated approvals
  • Fastest and slowest conversions to full approvals
  • Keytruda's 18 conditional approvals

Download Report