FAQs

What is ANKTIVA®?

ANKTIVA®, also known as N-803, is a novel immunotherapy, different than an immune checkpoint inhibitor, that enhances the body’s natural immune response by activating natural killer (NK) cells and T-cells. It is designed to improve the effectiveness of immune-based treatments, including treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ.

How does ANKTIVA® work?

ANKTIVA® works by targeting the IL-15 pathway, which is critical for the activation and proliferation of NK cells and T cells. By amplifying the immune response, ANKTIVA® enhances the body’s ability to recognize and destroy cancer cells while preserving healthy tissue.

Is ANKTIVA® FDA-approved?

ANKTIVA® is FDA-approved for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ with or without papillary tumors.

Treatment with BCG alone wasn’t effective. Why could using BCG with ANKTIVA® be different?

ANKTIVA® works differently and in concert with BCG. ANKTIVA’s immune-cell activator (interleukin-15) restores a response to BCG and increases the body’s disease-fighting NK cells, killer T cells, and memory T cells.1,2,3 ANKTIVA® has been shown in studies to work with BCG to effectively kill cancer cells, when BCG alone wasn’t effective.4 And it has been shown to lead to longer duration responses.

How do I know if I am a good candidate for ANKTIVA®?

It is important to discuss your options with your healthcare provider. They can help you evaluate whether a treatment involving ANKTIVA® would be right for you.

1. Felices M, Chu S, Kodal B, Bendzick L, Ryan C, Lenvik AJ, Boylan KLM, Wong HC, Skubitz APN, Miller JS et al: IL-15 super-agonist (ALT-803) enhances natural killer (NK) cell function against ovarian cancer. Gynecol Oncol 2017, 145(3):453-461. 2. Van der Meer JMR, Maas RJA, Guldevall K, Klarenaar K, de Jonge P, Evert JSH, van der Waart AB, Cany J, Safrit JT, Lee JH et al: IL-15 superagonist N-803 improves IFNγ production and killing of leukemia and ovarian cancer cells by CD34(+) progenitor-derived NK cells. Cancer Immunol Immunother 2020, 70(11):3367. 3. Fantini M, David JM, Wong HC, Annunziata CM, Arlen PM, Tsang KY: An IL-15 Superagonist, ALT-803, Enhances Antibody-Dependent Cell-Mediated Cytotoxicity Elicited by the Monoclonal Antibody NEO-201 Against Human Carcinoma Cells. Cancer Biother Radiopharm 2019, 34(3):147-159. 4. Chamie K, Chang Sam S, Kramolowsky E, Gonzalgo Mark L, Agarwal Piyush K, Bassett Jeffrey C, Bjurlin M, Cher Michael L, Clark W, Cowan Barrett E et al: IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer. NEJM Evidence 2022, 2(2200167):1-11.

Indication and Important Safety Information

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS

Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION

For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatchor call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)

ANKTIVA is a Novel Treatment for NMIBC CIS Patients Unresponsive to BCG

For more information, please call 1-877-ANKTIVA