On October 16, 2025, Artiva Biotherapeutics announced that the U.S. Food and Drug Administration granted Fast Track designation to its allogeneic natural killer cell therapy, AlloNK (AB‑101), for the treatment of refractory rheumatoid arthritis in combination with rituximab. The designation is intended to expedite the review process for therapies that address unmet medical needs.
AlloNK is the first drug candidate in the deep B‑cell depleting therapeutic category to receive Fast Track status for rheumatoid arthritis, a disease affecting more than 1.5 million U.S. patients, of whom an estimated 100,000 remain refractory to existing therapies. The designation underscores the potential of AlloNK to provide a deeper, more durable B‑cell depletion when paired with rituximab, potentially improving outcomes for patients who have exhausted standard treatment options.
The company has already treated more than 20 patients with AlloNK plus monoclonal antibody therapy across its company‑sponsored and investigator‑initiated trials. AlloNK’s off‑the‑shelf, cryopreserved formulation allows for outpatient administration, positioning it as a scalable and accessible option that could transform care for refractory rheumatoid arthritis.
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