ImmunityBio Inc. (NASDAQ: IBRX) announced that its cancer immunotherapy ANKTIVA is now commercially available in Saudi Arabia for patients with specific bladder and lung cancer indications.

The Saudi Food and Drug Authority approved ANKTIVA for two uses: in combination with Bacillus Calmette-Guérin for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, and in combination with immune checkpoint inhibitors for treating adult patients with metastatic non-small cell lung cancer.

The company achieved commercial availability within two months of announcing its Middle East and North Africa partnership with Biopharma and Cigalah Healthcare. ImmunityBio stated that initial patients have been identified for treatment across both approved indications.

ANKTIVA is being distributed through the partnerships with Biopharma and Cigalah Healthcare, supported by ImmunityBio's wholly owned subsidiary in Saudi Arabia.

"Thanks to our strategic partnership with Biopharma and Cigalah Healthcare, and despite a fluid situation in the region, we have been able to bring this innovative cancer treatment to patients ahead of the deadline we announced in February," said Richard Adcock, President and CEO of ImmunityBio.

The drug received U.S. Food and Drug Administration approval in April 2024 for bladder cancer treatment. It has subsequently received regulatory authorizations in the United Kingdom, European Union, Macau Special Administration Region of China, and Saudi Arabia.

The lung cancer indication in Saudi Arabia was approved under accelerated approval based on the increase of absolute lymphocyte count associated with overall survival in a single arm study, according to the press release.