ImmunityBio Granted FDA Expanded Access for ANKTIVA® to Treat Lymphopenia in Solid Tumour Patients
Tuesday, June 03, 2025
ImmunityBio has received authorisation from the United States Food and Drug Administration (FDA) for Expanded Access to its Cancer BioShield™ platform.
The Cancer BioShield platform is an integrated immunotherapy strategy aimed at restoring immune function by reversing lymphopenia. At its centre is ANKTIVA®, approved for use in non–muscle-invasive bladder cancer. This IL-15 superagonist activates and expands NK cells and CD4+/CD8+ T cells, helping to re-establish the immune system's capacity to fight cancer.
This platform, led by ANKTIVA® (nogapendekin alfa inbakicept-pmln), is now available for adult patients with refractory or relapsed solid tumours experiencing lymphopenia after standard first-line treatments such as chemotherapy, radiation, or immunotherapy.
Lymphopenia is a condition marked by the depletion of crucial immune cells, including natural killer (NK) cells and CD8+ and CD4+ T cells. It often arises as a side effect of cancer treatment and leaves patients vulnerable to infections and reduced immune response, which can accelerate cancer progression and lead to early mortality. Despite its significance, there have been no approved therapies specifically aimed at reversing lymphopenia until now.
While treatments like EPOGEN® and NEUPOGEN® have long addressed chemotherapy-induced anaemia and neutropenia, no similar option existed for lymphopenia. ANKTIVA, an interleukin-15 (IL-15) agonist, becomes the first therapy approved to restore lymphocyte levels. It promotes the activation and proliferation of NK and T cells without stimulating regulatory T cells (Tregs), which can suppress immune function.
In addition, ImmunityBio was granted Regenerative Medicine Advanced Therapy (RMAT) designation in early 2025 for ANKTIVA and CAR-NK (PD-L1 t-haNK), recognising their potential to meet serious unmet medical needs in cancer care.
Source: immunitybio.com
