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FDA Approves ImmunityBio’s Anktiva for the Treatment of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer


Approval comes amid positive results of a single-arm trial, showing a complete response rate of 77% in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

Image Credit: Adobe Stock Images/Adin

Image Credit: Adobe Stock Images/Adin

The FDA has approved ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln) for use in combination with Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. According to the company, the approval was based on results from a single-arm, multicenter trial, which included 77 evaluable patients. After 37 months of receiving the treatment, results showed a complete response (CR) rate of 62%, with some cases showing responses lasting over 47 months.1

“The FDA’s approval of Anktiva marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, MD, executive chairman, global chief scientific and medical officer, ImmunityBio, in a press release. “Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. This novel mechanism of action, which mimics the biology of the dendtritic cell, begins the evolution of immunotherapy beyond T cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses. The ‘triangle offense’ of tumor cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin.”

Last May, the FDA issued a Complete Response Letter (CRL) to ImmunityBio’s initial Biologics License Application (BLA) filing for Anktiva. After making proper adjustments, the FDA accepted a BLA resubmission in October.2

“We are pleased that the FDA has accepted ImmunityBio’s resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission. We look forward to working closely with the Agency to finalize the review and to bringing this important immune-enhancing therapeutic to patients suffering from bladder cancer,” said Soon-Shiong, in a press release.

According to the American Cancer Society (ACA), bladder cancer rates accelerated by 1.7% from 2015 to 2019, after initial decreases throughout the 2000s. In 2024, statistics show approximately 83,190 new cases of bladder cancer, with close to 16,840 deaths. Typically, bladder cancer manifests in individuals over the age of 55 years, with the average age of diagnosis being 73 years.3

“About half of all bladder cancers are first found while the cancer is still only in the inner layer of the bladder wall (These are non-invasive or in situ cancers),” reports the ACA. “About 1 in 3 bladder cancers have spread into deeper layers of the bladder wall but are still only in the bladder. In most of the remaining cases, the cancer has spread to nearby tissues or lymph nodes outside the bladder. Rarely (in about 5% of cases), it has spread to distant parts of the body.”

Anktiva, which was previously granted a Breakthrough Therapy Designation by the FDA, is expected to be available in the United States beginning next month.1

“The long duration of complete response ranging over 47 months is a game changer for NMIBC patients and provides further clinical evidence of Anktiva’s effectiveness for patients who historically have faced high rates of recurrence and significantly diminished quality of life due to radical surgeries,” said Karim Chamie, MD, Associate Professor of Urology, UCLA, principal investigator for the QUILT 3.032 study, in the press release. “With this approval, ANKTIVA could represent a new standard of care for patients with NMIBC and has the potential to change the way we treat bladder cancer.”


1. ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. ImmunityBio. April 22, 2024. Accessed April 23, 2024. https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/

2. FDA Accepts ImmunityBio’s BLA Resubmission as Complete and Sets New PDUFA Date. ImmunityBio. October 26, 2023. Accessed April 23, 2024. https://immunitybio.com/fda-accepts-immunitybios-bla-resubmission-as-complete-and-sets-new-pdufa-date/

3. Key Statistics for Bladder Cancer. ACA. Accessed April 23, 2024. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html#:~:text=time%20of%20diagnosis-,How%20common%20is%20bladder%20cancer%3F,men%20and%204%2C550%20in%20women)

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