Saudi FDA grants accelerated approval for ImmunityBio's ANKTIVA in NSCLC and NMIBC

ImmunityBio, Inc.

SFDA approved ANKTIVA + checkpoint inhibitor for metastatic NSCLC after standard-of-care failure; first worldwide approval for this subcutaneous IL-15 agonist.
Approval based on QUILT-3.055 and QUILT-2.023 showing lymphocyte recovery and survival association; confirmatory trial ResQ-201A recruiting.
SFDA also approved ANKTIVA + BCG for BCG-unresponsive NMIBC with CIS, adding to U.S., U.K., and conditional EU approvals.
ImmunityBio plans regional office in Saudi Arabia and partner Biopharma Cigalah for MENA commercial distribution; NMIBC trial enrollment ahead of schedule, BLA submission by year-end.

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