February 2024 Brief

If FDA-approved, epcoritamab would be the first and only subcutaneous bispecific antibody indicated for the treatment of adult patients with relapsed/refractory follicular lymphoma after 2 rounds of previous therapy.

The FDA has granted a breakthrough therapy designation to BAY 2927088 for the treatment of non-small cell lung cancer harboring HER2-activating mutations.

Approval for melphalan flufenamide has been withdrawn by the FDA due to the failure of its confirmatory trial to demonstrate its clinical benefit and the lack of evidence supporting its safety and effectiveness.

A fast track designation has been granted to 9MW2821 by the FDA for patients with advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The natural killer cell therapy IDP-023 is being studied in a phase 1 trial for the treatment of patients with non-Hodgkin lymphoma and multiple myeloma.

Here’s a look back on all the FDA happenings from the month of February 2024.