Saudi FDA Grants Accelerated Approval to ImmunityBio’s ANKTIVA® In Combination with Checkpoint Inhibitors for Metastatic Non-Small Cell Lung Cancer
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
ANKTIVA, in combination with an immune checkpoint inhibitor, has received accelerated approval from the Saudi Food and Drug Authority for the treatment of metastatic non-small cell lung cancer, marking the first approval in the world of a subcutaneously administered IL-15 receptor superagonist that restores immune competenceANKTIVA + checkpoint inhibitor represents the first approved chemotherapy-free immunotherapy that activates both natural killer cells and killer T cells, heralding the era of immunotherapy 2.0Accelerated approval was granted following SFDA review of clinical data from QUILT-3.055 in second-line and greater NSCLC patients and QUILT-2.023 in first-line NSCLC demonstrating significant immune restoration and a consistent association between lymphocyte recovery with improved survival in checkpoint-experienced patientsNewly approved therapy supports ImmunityBio’s mission to provide access to patients globally who could benefit from this chemotherapy-free combination trea
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IBRX
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- 5/12/25 - Miss
IBRX
Sec Filings
- 1/16/26 - Form 144
- 1/15/26 - Form 8-K
- 1/14/26 - Form 8-K
- IBRX's page on the SEC website