ImmunityBio, Inc. (NASDAQ: IBRX) has received Expanded Access authorization from the U.S. Food and Drug Administration (FDA) for its Cancer BioShield™ platform, featuring ANKTIVA® (nogapendekin alfa inbakicept-pmln). This authorization allows the treatment of lymphopenia, a life-threatening immune deficiency, in adult patients with refractory or relapsed solid tumors who have progressed after first-line standard therapies such as chemotherapy, radiation, or immunotherapy. This significant regulatory approval provides new hope for patients with solid tumors experiencing immune collapse, offering an innovative approach to cancer care by restoring lymphocyte levels and potentially altering disease progression. The positive survival outcomes observed in metastatic pancreatic cancer patients at the ASCO Annual Meeting 2025 underscore the potential impact of this treatment.
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