FDA RMAT designation for ImmunityBio’s Anktiva

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva (nogapendekin alfa inbakicept-pmln) and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer.

The treatment is under development by California, USA-based immunotherapy company ImmunityBio (Nasdaq: IBRX), whose shares shot up 15% to $3.29 on the news.

Anktiva is the first US Food and Drug Administration (FDA) approved molecule that has demonstrated the ability to increase lymphocytes via its proliferative interleukin (IL)-15 stimulatory action, having won an FDA nod in April 2024  for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer  following a previous rejection. The drug was also approved in Europe in January this year.