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Cancer Treatment Granted Lymphopenia Indication

June 4, 2025 • 5:34 am CDT
Pixabay 2025
(Vax-Before-Travel News)

ImmunityBio, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the use of its Cancer BioShield™ platform, anchored by ANKTIVA®, to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy.

On June 2, 2025, ImmunityBio stated 'while oncologists and patients have long had therapies such as EPOGEN® and NEUPOGEN® to manage chemotherapy- and radiation-induced anemia and neutropenia, no comparable option has been available for lymphopenia.'

To date no treatment exists for lymphopenia, a depletion of critical lymphocytes responsible for immunogenic cell death, specifically natural killer (NK) cells, killer CD8+ T cells and CD4+ with memory T cells.

Treatment-induced lymphopenia is a debilitating consequence of chemotherapy, radiation, specific immunotherapies, and steroids. This treatment-acquired immunodeficiency not only increases susceptibility to infections but also deprives the body’s immune system to fight residual or recurrent cancer, accelerating metastasis and disease progression, and contributing to early mortality.

Countless publications over the last two decades have reported lymphopenia as a highly predictive biomarker of poor prognosis across all tumor types.1-6 Despite its significant clinical impact, the pharmaceutical industry has largely overlooked lymphopenia as a disease in its own right, and no approved therapies have existed to directly address it, until the approval of ANKTIVA in the treatment of BCG-unresponsive bladder cancer with the mechanism of action of an IL-15 superagonist proliferating key lymphocytes.

Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, commented in a related press release, “This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA."

"The survival benefit we observed at ASCO 2025 in 3rd to 6th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels—rather than depleting them—can change the course of disease.”

As of June 4, 2025, ANKTIVA is available at participating cancer centers in the United States and other countries, such as the Kingdom of Saudi Arabia.

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