ImmunityBio's ANKTIVA Receives FDA Approval for BCG-Unresponsive Bladder Cancer Treatment at VA Hospital

ImmunityBio (IBRX) announced that the Michael E. DeBakey Department of Veterans Affairs Medical Center in Houston is one of the first VA hospitals to administer ANKTIVA, a treatment for BCG-unresponsive non-muscle invasive bladder cancer. ANKTIVA is approved by the FDA for use in combination with BCG.

ImmunityBio, Inc. (NASDAQ: IBRX), a leading biotechnology company focused on immunotherapy, has announced that the Michael E. DeBakey Department of Veterans Affairs Medical Center in Houston has become one of the first VA hospitals in the Houston region and the U.S. to administer ANKTIVA® (nogapendekin alfa inbakicept-pmln) to a veteran with bladder cancer. ANKTIVA, a novel immune-boosting agent, is approved by the FDA in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex designed to activate NK and CD8+ killer T cells, which are crucial in fighting cancer cells. This treatment is particularly vital for veterans, given a 2024 study that linked military exposure to carcinogenic agents with a higher risk of bladder cancer among veterans. Nationally recognized urologic oncologists Dr. Jeffrey Jones and Dr. Jennifer Taylor at the Houston VA were instrumental in bringing this novel treatment to veterans. They are strong advocates for advancing care for those battling bladder cancer and led efforts to enroll the facility in ImmunityBio’s Expanded Access Program (EAP) for rBCG.

“We are honored to see ANKTIVA reaching our nation’s veterans,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “Drs. Jones’ and Taylor’s leadership and commitment to innovation are exactly what’s needed to expand access to transformative treatments like ANKTIVA across the VA system. This milestone at DeBakey underscores the real-world impact of our mission.”

ANKTIVA was approved by the FDA in 2024 for use in the United States with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors. ImmunityBio is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that aim to reduce or eliminate the need for standard high-dose chemotherapy.

References:
[1] https://immunitybio.com/immunitybio-announces-houstons-michael-e-debakey-va-medical-center-is-among-the-first-va-hospitals-to-administer-anktiva-to-bladder-cancer-patients/