Reaffirming our Commitment to Advertising Compliance

CORRECTIVE COMMUNICATION REGARDING ANKTIVA®

(nogapendekin alfa inbakicept-pmln) solution, for intravesical use

In March, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter regarding ANKTIVA communications. Specifically, OPDP identified a direct-to-consumer (DTC) television advertisement and a DTC episode of The Sean Spicer Show podcast as misleading. The television advertisement cited by OPDP was never broadcast. The podcast episode featured ImmunityBio’s Founder and Executive Chairman, Dr. Patrick Soon-Shiong, as a guest to discuss his vision for the company’s drug development pipeline and underlying science supporting cancer treatment. OPDP viewed Dr. Soon-Shiong’s statements as promotional communications about ANKTIVA and found them to be misleading.

OPDP determined that the podcast episode included misleading statements about treatment efficacy and safety, omitted material facts, and failed to provide adequate directions for use with ANKTIVA. For example, OPDP challenged statements about creating a “cancer vaccine,” describing interleukin-15 (IL-15) as a molecule that “could cure cancer,” and citing ANKTIVA as a therapy to “prevent cancer,” “treat all cancers,” and be administered via injection. The podcast episode did not include any information about the risks and consequences that may result from treatment, which OPDP determined as creating a misleading impression about the safety of ANKTIVA. Finally, the podcast episode was determined to be misleading because it did not include the complete FDA-approved indication for ANKTIVA.

The following information is provided to correct the concerns cited in OPDP’s Warning Letter:

  • Indication: ANKTIVA is an 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.
    • ANKTIVA is not approved to treat any other cancers, or to cure or prevent cancer, or as a cancer vaccine. During the podcast episode, the characterization of the IL-15 molecule as a promising “cancer cure” was based on an independent assessment by the National Cancer Institute (NCI) during a July 2007 Immunotherapy Agent Workshop.[i] Mentions of “cancer vaccines” were intended to describe the mechanistic potential of immunotherapies that induce memory T cells, a fundamental goal of the company’s long-term development and research strategy.[ii]
  • ANKTIVA is approved only in combination with BCG and not as a single agent or first-line therapy.
  • ANKTIVA is approved and administered for intravesical use only, and not via injection or any other route of administration.
  • The efficacy of ANKTIVA with BCG was evaluated in a single-arm study with the primary efficacy endpoints measuring complete response and duration of response. Secondary endpoints from the pivotal clinical trial, including cystectomy avoidance and disease-specific survival, are viewed as uninterpretable by FDA without an appropriate control or comparator.
  • ImmunityBio is currently evaluating IL-15 (ANKTIVA) under FDA-approved investigational new drug (IND) applications and FDA-authorized investigational programs, such as single patient INDs through the company’s expanded access and compassionate use program. These investigational uses include multiple oncology indications, as well as use as single agent therapy, first line therapy, and different routes of administration. Such uses are not currently approved by the FDA.
  • Please review the Important Safety Information for ANKTIVA below. For more information about ANKTIVA, please read the Full Prescribing Information, visit anktiva.com, and talk to your healthcare provider.

 

IMPORTANT SAFETY INFORMATION FOR ANKTIVA

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 Intravesical 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. ANKTIVA may cause fetal harm. Because of the potential risk to the fetus, females of reproductive potential should 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.

[i] Cheever, Martin A. Twelve immunotherapy drugs that could cure cancers. Immunological Reviews. 2008;222(1):357-368. Doi:10:1111/j.1600-065X.2008.00604.x.

[ii] Kartikasari AER, Prakash MD, Cox M, Wilson K, Boer JC, Cauchi JA, Plebanski M. Therapeutic Cancer Vaccines—T Cell Responses and Epigenetic Modulation. Front Immunol. 2019 Jan 25;9:3109.