FDA Greenlights Lifeline: ANKTIVA® Unleashed to Rebuild Immune Defenses in Cancer's Toughest Battles
- Breaking News: The FDA grants Expanded Access for ImmunityBio's ANKTIVA®, part of the Cancer BioShield™ platform, to combat lymphopenia in patients with advanced solid tumors.
- The Unseen Enemy: Lymphopenia, a devastating depletion of vital immune cells caused by cancer treatments, has long been an unaddressed crisis, worsening prognoses6, 3.
- A New Dawn: ANKTIVA® is the first approved therapy designed to restore these critical lymphocytes, offering a chance to reawaken the body's power to fight cancer4, 5.
In a landmark decision, the U.S. Food and Drug Administration (FDA) has thrown a vital lifeline to cancer patients grappling with the silent saboteur of their recovery: lymphopenia. ImmunityBio today announced Expanded Access authorization for its revolutionary Cancer BioShield™ platform, headlined by ANKTIVA® (nogapendekin alfa inbakicept-pmln), to treat this crippling immune deficiency in adult patients with refractory or relapsed solid tumors who have exhausted standard treatments6, 1.
For too long, lymphopenia—a severe depletion of crucial cancer-fighting lymphocytes like NK cells, killer CD8+ T cells, and CD4+ memory T cells—has been a devastating, yet overlooked, consequence of chemotherapy, radiation, and even some immunotherapies6, 3, 2. This treatment-induced immunodeficiency not only heightens infection risk but critically undermines the body's ability to fight residual or recurrent cancer, paving the way for metastasis and earlier mortality6, 3. While treatments like EPOGEN and NEUPOGEN address anemia and neutropenia, lymphopenia remained an unmet medical crisis—until now.
ANKTIVA®, a cutting-edge interleukin-15 (IL-15) agonist, is the first approved therapy with a defined mechanism to specifically rebuild these essential immune warriors, activating and proliferating NK and T cells without boosting immunosuppressive cells4, 5. "Lymphopenia has long been recognized as a major driver and predictor of early mortality in cancer—yet until now, it has remained unaddressed," declared Dr. Patrick Soon-Shiong, Founder and Executive Chairman of ImmunityBio. "This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy... to access ANKTIVA."
The promise of ANKTIVA® is already shining through. ImmunityBio's presentation at the 2025 ASCO Annual Meeting showed that reversing lymphopenia with ANKTIVA and CAR-NK therapy significantly prolonged survival in late-stage metastatic pancreatic cancer. One remarkable patient with metastatic pancreatic cancer, treated with the full Cancer BioShield™ platform, has remained in remission for over six years, maintaining a high quality of life.
"We are entering a new era in oncology where the goal is not only to target the tumor but to protect and empower the immune system itself," Dr. Soon-Shiong continued. This Expanded Access Program isn't just a trial; it's a beacon of hope, offering a chance to "transform cancer care by reversing the immune collapse." ANKTIVA aims to serve as a true "Cancer BioShield," enabling the body to regenerate its own defenses against the onslaught of cancer.
With this authorization, the battle lines against cancer are being redrawn, shifting focus to not just attacking the disease, but fortifying the patient's own incredible capacity to heal and fight.
For more information, visit ImmunityBio's Founder’s Vision and connect on Twitter, LinkedIn, Facebook, and YouTube.
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