About Non-Muscle 
Invasive Bladder Cancer

NMIBC is a type of cancer that grows on the inside lining of the bladder

The bladder is a hollow, balloon-like organ in which urine is stored. NMIBC, which is cancer that has grown only on the lining of the bladder and not into the muscle layer underneath, is the most common form of bladder cancer. NMIBC carcinoma in situ (CIS) is a critical subtype of NMIBC that is a high-grade, flat, and superficial form of bladder cancer.

Unlike other types of NMIBC that might form tumors or masses, CIS appears as a flat lesion on the bladder lining. It is characterized by abnormal cells that are confined to the bladder’s mucosal surface without invading the deeper layers of the bladder wall.

For NMIBC that is likely to keep growing (intermediate or high risk), BCG by itself is a common first therapy, and about 60% of patients with NMIBC will have a complete response.1,2 But in an estimated 30-40% of NMIBC patients, BCG will not work long-term, and the cancer will recur.2 For these BCG-unresponsive cases, there are only a few approved treatment options to try before surgical removal of the bladder (cystectomy) is recommended. But there is a reason for people with BCG-unresponsive NMIBC to feel hopeful – ANKTIVA® plus BCG – is an approved treatment option for BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease that offers a chance for them to keep their bladder.

1. Sylvester RJ, van der Meijden AP, Oosterlinck W, et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol 2011;49:466-477. DOI: 10.1016/j.eururo.2005.12.031.

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.

Learn More

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.

Learn More

ANKTIVA Resources

Learn more about the clinical story of ANKTIVA

Peer-reviewed Paper

Getting Started with ANKTIVA for Patients

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

Download PDF

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