ImmunityBio Secures SFDA Approval, Launches ANKTIVA in Saudi Arabia for Bladder and Lung Cancer
ImmunityBio’s ANKTIVA is now commercially available in Saudi Arabia for BCG-unresponsive non-muscle invasive bladder cancer and metastatic non-small cell lung cancer, following SFDA approvals and partnerships with Biopharma and Cigalah Healthcare. Market entry was achieved within two months of the MENA collaboration, enabling patient treatment across indications.
1. Market Entry and Approvals
ANKTIVA received SFDA authorizations in January 2026 for use in BCG-unresponsive non-muscle invasive bladder cancer and in combination with checkpoint inhibitors for metastatic NSCLC, with commercial launch executed in Saudi Arabia as of April 2026. This launch was completed within two months of the MENA partnership agreement, surpassing the February target deadline.
2. Partnerships and Distribution
ImmunityBio is partnering with Biopharma and Cigalah Healthcare for distribution in Saudi Arabia, leveraging its wholly owned local subsidiary to facilitate logistics and support. Both partners are established regional distributors, enabling rapid product rollout across key oncology clinics.
3. Clinical Indications and Patient Access
ANKTIVA is indicated with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer and with checkpoint inhibitors for adult metastatic non-small cell lung cancer patients who progressed on standard therapies. Initial patient identification is underway across both approved indications.
4. Revenue and Growth Impact
Commercial availability in Saudi Arabia opens a sizeable oncology market where lung and bladder cancers are prevalent, creating a new revenue stream for ImmunityBio. Successful market entry could drive similar launches across the Middle East and North Africa, expanding the company’s global footprint.