FDA agrees to revisit rare blood cancer drug Ebvallo after companies address concerns

Two companies developing a therapy for a rare blood cancer have reached an agreement with the FDA to address the agency’s concerns about their drug Ebvallo.

The FDA had previously rejected Ebvallo in January, citing that the single‑arm clinical trial was flawed and the data insufficient to support approval.

In a meeting held in late April, FDA officials accepted that the completed single‑arm trial meets the evidentiary standards for review, opening the path toward possible approval.

The agreement does not constitute an approval, but it removes the primary regulatory obstacle that halted the drug’s progress.