Why is ANKTIVA® Right for You?

ANKTIVA is an Immunotherapy that Activates Your Body’s Cancer Fighting Cells

ANKTIVA® is the first U.S. FDA-approved immunotherapy that activates a type of cell called a natural killer (NK) cell, part of the body’s natural immune system, to attack and kill non-muscle invasive bladder cancer (NMIBC) cells.1,2 ANKTIVA is a treatment for use in combination with a standard treatment for NMIBC, bacillus Calmette-Guérin (BCG), for people with NMIBC for whom BCG alone was not effective or in whom NMIBC returned after initial successful treatment. These people have what is termed BCG-unresponsive NMIBC. ANKTIVA plus BCG is an option for people with BCG-unresponsive NMIBC carcinoma in situ (CIS) who are unable or unwilling to have their bladder surgically removed.

91%
of patients who responded to ANKTIVA were able to keep their bladders at 12 months and 88.1% at 24 months2
(n=82)
62%
of patients had their NMIBC eliminated1
(n=77) (95% CI=51,73)
(FDA Efficacy Population)
47+ Months
duration of response and ongoing1
(FDA Efficacy Population)
58%
of patients remained NMIBC CIS-free at 12 months1
((FDA Efficacy Population)

1. ANKTIVA Package insert. lmmunityBio, Inc.; 2024. 2. Chamie K, et al. IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. NEJM Evid. 2023 Jan;2(1): EVIDoa2200167. doi: 10.1056/EVIDoa2200167.

Who Should Consider ANKTIVA?

ANKTIVA is a treatment for adults who have all the following:

  • High-risk non-muscle invasive bladder cancer
  • NMIBC that did not or is no longer responding to BCG therapy alone (BCG-unresponsive)
  • NMIBC that has not grown beyond the inner lining of the bladder to the muscle underneath (called carcinoma in situ or CIS disease)
  • NMIBC with or without small finger-like tumor growths that project away from the bladder wall into the bladder (papillary disease)

If You Have Been Diagnosed with BCG-Unresponsive NMIBC CIS Disease
and are Interested in ANKTIVA, Here is What You Need to Know:

What ANKTIVA is

  • ANKTIVA is an immunotherapy that activates 
your body’s cancer fighting cells
  • ANKTIVA is used in combination with BCG and is administered directly into your bladder via a catheter
  • ANKTIVA is the first treatment of its type approved to treat BCG-unresponsive NMIBC
  • ANKTIVA can be administered in a clinical setting and allows you to remain in the care of your urologist

What ANKTIVA is not

  • ANKTIVA is not a chemotherapy or gene therapy
  • ANKTIVA is not administered via an IV and does not circulate throughout your body. It only fights cancer in the bladder. This may reduce side effects 
  • ANKTIVA is not a chemical, it is a biologic that is similar to molecules produced naturally by your body
  • ANKTIVA does not require you to change providers for treatment

Getting Started with ANKTIVA for Patients

A patient-friendly overview of how ANKTIVA plus BCG work together, as well as what patients should expect before and after treatment

Patient Stories

Read about patients who participated in the clinical trials for ANKTIVA

Irv’s Journey

Irv’s Journey

He was first diagnosed with bladder cancer in 2016, when 
on Thanksgiving day, he had several concerning symptoms including blood in his urine. Several tumors on the interior surface of his bladder were removed by his local urologist, 
who treated him with BCG. Unfortunately, he failed to respond and the tumors came back. He was afraid he was going to lose his bladder.

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Wayne’s Journey

Wayne’s Journey

Wayne has lived a rich life with his wife, two daughters, and three grandchildren. He describes himself as someone who “just likes people”. When he was first told, “you might have a tumor in your bladder”, he became very concerned, especially when he learned his first treatment with BCG wasn’t working. Wayne feels lucky that a friend told him about a clinical trial for patients like himself who were not cured by BCG alone.

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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