Posted by Michael Wonder on 28 Feb 2025
ImmunityBio receives FDA RMAT designation for Anktiva and CAR-NK for the reversal of lymphopaenia in patients receiving standard of care chemotherapy/radiotherapy and in treatment of multiply relapsed locally advanced or metastatic pancreatic cancer
27 February 2025 - Regenerative medicine advanced therapy designation follows clinical data of absolute lymphocyte count and significant overall survival correlations in QUILT trials across multiple tumour types, including third line or greater metastatic pancreatic cancer, checkpoint relapsed non-small cell lung cancer, and supportive data from healthy volunteers.
ImmunityBio today announced the US FDA has granted regenerative medicine advanced therapy designation for Anktiva and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopaenia in patients receiving standard of care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer.
