Saudi FDA Approves ImmunityBio’s ANKTIVA for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Reuters

Jan 14

Saudi FDA Approves ImmunityBio’s ANKTIVA for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

ImmunityBio, Inc. has announced that the Saudi Food and Drug Authority (SFDA) has granted approval for ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin $(BCG)$ for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. This approval adds to existing regulatory clearances for ANKTIVA in the United States and United Kingdom, as well as conditional approval in the European Union. The decision by the SFDA follows a review of data from the QUILT-3.032 study. ImmunityBio is continuing its expansion efforts in the Middle East and North Africa, including opening a regional office in Saudi Arabia and collaborating with Biopharma Cigalah as a commercial and distribution partner in the region.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immunitybio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260114174640) on January 14, 2026, and is solely responsible for the information contained therein.

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This approval adds to existing regulatory clearances for ANKTIVA in the United States and United Kingdom, as well as conditional approval in the European Union. The decision by the SFDA follows a review of data from the QUILT-3.032 study. ImmunityBio is continuing its expansion efforts in the Middle East and North Africa, including opening a regional office in Saudi Arabia and collaborating with Biopharma Cigalah as a commercial and distribution partner in the region.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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