'Epkinly (epcoritamab),' the first T-cell–engaging bispecific antibody, was found to have been approved under the condition that the company submits Phase III trial data.

In Korea, the approval was granted on March 20 based on Phase II clinical trial data and a Phase III trial protocol, but at the time, a condition was added that the company must submit data from a therapeutic confirmatory trial.

According to the minutes of the Central Pharmaceutical Affairs Committee meeting held in April, which were recently released by the Ministry of Food and Drug Safety, Epkinly was granted conditional approval and was required to submit Phase III trial results after the approval of the p