FDA actions in brief

Tarlatamab — now with the brand name Imdelltra — is the first approved bispecific antibody for a solid tumor.

Breyanzi is now included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a recommendation for third-line therapy for relapsed or refractory follicular lymphoma.

If approved, the Leqembi autoinjector could be used to administer the treatment for Alzheimer’s disease at home or at medical facilities.

Regulators are now working to complete their review of the BLA for mRNA-1345 by the end of May 2024. mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices in June 2024.

If approved, midomafetamine would be the first psychedelic-assisted therapy approved for any mental health condition. The advisory committee meeting is June 4, 2024.

Zenocutuzumab is a new type of bispecific antibody that target both HER2 and HER3 proteins to inhibit NRG1 binding and blocking the mechanism for tumor survival. The FDA’s target date is in December 2024.