Today’s articles cover the big picture, setting the stage with a data-rich analysis by Executive Editor Selina Koch of the promise and problems of accelerated approval and an in-depth case study of the pathway’s use in cancer. These are accompanied by a data graphic on the poster child of accelerated approval, Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), by Director of Data & Analytics Winnie Pong.

To view Monday's Back to School content, click on the links below:

Editor’s letter: Back to School 2021
Stretching the vision of accelerated approval

The promise and problems of expediting drug approvals
⁠Overview of status of expedited approval pathways sets stage for BioCentury's 29th Back to School

What accelerated approval has done for cancer
⁠Cancer provides case studies for the good and bad of accelerated approval

Keytruda’s master class in accelerated approval
⁠Merck's Keytruda land grab has relied on strategic use of accelerated approval pathway

Accelerated approval’s big picture: a BioCentury Back to School podcast
⁠BioCentury's editors assess opportunities, challenges for expedited approval pathway


Podcast preview: Accelerated approval’s big picture

Full podcast now available

Back to School 2021

⁠Stretching the vision of accelerated approval


At some snapshots in time, one issue bubbles to the surface, demanding attention and solutions to problems that have been simmering for years.

Right now, that issue is accelerated approval.

BioCentury’s 29th Back to School project examines the future of accelerated and conditional approvals globally, and stretches the vision of what these pathways could achieve.

FDA’s accelerated approval pathway, introduced in 1992, has spawned similar schemes in Europe, Japan, China and the U.K., each of which added nuanced changes but based their pathways on the same idea — granting approval for a drug on the basis of less data than for full approval, to expedite treatments to patients with severe disease and no alternatives, on the condition that data collection will continue postmarket; if the evidence does not uphold the risk-benefit assessment, the drug or an indication can be withdrawn. 

The catalyst for the current furor was FDA’s surprising and controversial decision to grant accelerated approval to Aduhelm aducanumab-avwa, the Alzheimer’s therapy from Biogen Inc. (NASDAQ:BIIB). But the issues go far beyond Aduhelm, and far wider than the pathway in the U.S... READ MORE