BioCentury
ARTICLE | Regulation

FDA’s 2022 approvals: oncology lulls while innovation rises

A review of FDA’s 2022 approvals identifies a drop in cancer approvals amid broader target, modality advances

December 23, 2022 12:49 AM UTC
Updated on Jan 5, 2023 at 1:33 AM UTC

It was a slow year for FDA approvals, and for new cancer drug approvals in particular, but the drugs that did emerge from the regulatory process in 2022 reflect a level of innovation across targets, modalities and indications that is unmatched by previous years. 

A combination of bear market impacts and pandemic-related clinical and regulatory disruptions likely contributed to the smaller number of new drug approvals in 2022. The disproportionate effect on oncology may suggest two shifts in regulatory requirements for cancer drugs are showing their first effects in the 2022 approval class...