The US Food and Drug Administration (FDA) has granted expanded access authorisation for ImmunityBio’s Cancer BioShield platform, anchored by Anktiva (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adults with refractory or relapsed solid tumours.
The approval applies regardless of tumour type and is intended for those who have progressed after first-line standard-of-care treatments, including radiation, chemotherapy or immunotherapy.
Go deeper with GlobalData
Lymphopenia refers to the depletion of critical lymphocytes that are responsible for immunogenic cell death.
Treatment-induced lymphopenia can be a consequence of radiation therapy, chemotherapy and certain immunotherapies, as well as steroids.
Anktiva is designed specifically to address Bacille Calmette-Guérin (BCG)-unresponsive bladder cancer through its mechanism as an interleukin-15 (IL-15) superagonist that proliferates key lymphocytes.
As an IL-15 agonist, Anktiva becomes the first approved therapy with a defined mechanism aimed at restoring levels of the vital immune cells without inducing regulatory T cells, thus providing a solution to reverse this critical immune deficit among cancer patients.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataRecent results have indicated that reversing lymphopenia using both Anktiva and chimeric antigen receptor-natural killer therapy prolongs median overall survival rates among patients with third to sixth-line metastatic pancreatic cancer.
Enhanced benefits were observed when treatment commenced at lower tumour burdens indicated by CA19-9 levels.
ImmunityBio founder, executive chairman and global chief scientific and medical officer Dr Patrick Soon-Shiong stated: “Lymphopenia has long been recognised as a major driver and predictor of early mortality in cancer — yet until now, it has remained unaddressed.
“This FDA authorisation allows all patients with solid tumours suffering from immune collapse following first-line therapy of chemo, radiation or immunotherapy to access Anktiva.”
In February 2025, ImmunityBio announced the receipt of regenerative medicine advanced therapy designation from the FDA concerning both Anktiva and CAR-NK.
