Two biopharmaceutical companies have reached an agreement with the U.S. Food and Drug Administration (FDA) to revisit the rejection of a therapy for a rare blood cancer. Pierre Fabre Pharmaceuticals and Atara Biotherapeutics, the developers of the drug Ebvallo, announced on Thursday that a late April meeting with FDA officials resulted in the agency withdrawing its primary objection to the drug’s approval.
The FDA had previously rejected Ebvallo in January, citing concerns that the single-arm clinical trial supporting the drug’s application was flawed and its data “insufficient” for approval. The review was conducted by the FDA’s Center for Biologics Evaluation and Research, which was led at the time by Vinay Prasad. Prasad left the agency at the end of April.
During the April meeting, FDA officials agreed that the completed clinical trial met the necessary standards for review. This decision paves the way for a potential approval of Ebvallo, a therapy designed to treat a rare form of blood cancer.
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