Atara, Pierre Fabre's cell therapy to get another shot at FDA approval
Max Gelman / endpoints - There's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an approval, Atara said ...
AI Summary: Regulators have agreed to re-examine a previously rejected cell‑therapy application for a rare lymphoma, giving the Atara‑Pierre Fabre program another opportunity at approval. The decision follows additional data and stakeholder engagement, offering the developer a second bite at the apple and patients a renewed, if cautious, hope for a novel treatment pathway.
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