FDA Guidelines on the Provision of Information to the News Media, page-17

Hey guys FDA can also give ryoncil whats known as an accelerated FDA approval Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials.

If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval

On August 5, 2020, the Food and Drug Administration granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent..


The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need.

The faster approval relies on use of surrogate endpoints.