Partner in Progress: ImmunityBio

The people of ImmunityBio work tirelessly to transform their living biological technologies into innovative treatments that will improve the lives of people around the world. Their goal is to leverage and harmonize with the body’s immune system to clear disease while ensuring their therapies also protect the immune system from damage. This includes their bladder cancer therapy, ANKTIVA®.

What is ANKTIVA®?

ANKTIVA is the first FDA-approved immunotherapy designed to activate the body’s natural immune system to target and attack BCG-unresponsive non-muscle invasive bladder CIS (NMIBC CIS), potentially leading to a long duration of complete response with some patients exceeding 53+ months.  In the pivotal clinical trial, treatment of participants with BCG-unresponsive NMIBC CIS with or without papillary disease with ANKTIVA plus BCG was found to be well-tolerated and effective.

ANKTIVA is used in combination with a standard treatment called Bacillus Calmette-Guérin (BCG) for people with NMIBC whose cancer did not respond to BCG alone, or whose NMIBC returned after initial successful treatment. This condition is known as BCG-unresponsive NMIBC.

You can learn more about Anktiva in ImmunityBio’s Getting Started Guide for patients.

Who Qualifies to Receive ANKTIVA?

ANKTIVA is a treatment option for adults who meet all of the following criteria:

• Have high-risk NMIBC carcinoma in situ (CIS)
• Have BCG-unresponsive NMIBC (did not or is no longer responding to BCG alone)
• Have NMIBC that has not spread into the bladder muscle (remains within the inner lining)
• May or may not have papillary disease, which are small, finger-like tumor growths that extend into the bladder

How is ANKTIVA Administered?

ANKTIVA and BCG are combined in one syringe and administered directly into the bladder through a tube called a catheter. The procedure is performed by a urologist (or qualified health care provider) once a week for six weeks. This is the same process as when BCG is administered alone. 
The post-treatment directions are like those for after BCG treatment as well. A second treatment course may be administered if the tumor does not 
shrink at three months.

Justin’s Journey

Patient Assistance Program

The ImmunityBio CARE™ program is designed to help patients access ImmunityBio’s innovative treatment for BCG-unresponsive NMIBC CIS. The program offers services and resources to help determine if your insurance covers ANKTIVA®, including:

• Benefits investigation
• Prior authorization support and tracking
• Coding and billing assistance
• Claim denial guidance
• Payer-specific appeal assistance

More information for patients and healthcare professionals is available at Anktiva.com or by calling 1-877-ANKTIVA (1-877-265-8482).

Important Safety Information:

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (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/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482).

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