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ImmunityBio and Rafa Announce Israeli Ministry of Health Approval of ANKTIVA® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ

IBRX
  • The Israeli Ministry of Health granted approval for ANKTIVA® (nogapendekin alfa inbakicept) in combination with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ.
  • Approval was granted four months after submission under an accelerated review pathway, with the registration license expected within the coming weeks.
  • Rafa Laboratories will serve as the exclusive commercialization partner for ANKTIVA in Israel under a distribution agreement with ImmunityBio.
  • ANKTIVA is a first-in-class IL-15 receptor agonist immunotherapy authorized in 35 countries, designed to activate NK cells and T cells.
  • The U.S. FDA previously approved ANKTIVA in April 2024 for the same indication, with subsequent label expansion to include patients with papillary-only disease.
  • Bladder cancer represents a significant public health concern in Israel, ranking as the fourth most common cancer among men with 1,775 diagnoses in 2018.
  • Current guidelines recommend radical cystectomy for BCG-unresponsive high-risk NMIBC, creating an unmet medical need for bladder-preserving treatment options.
  • The most common adverse reactions for ANKTIVA include increased creatinine, dysuria, hematuria, urinary frequency, urinary tract infection, musculoskeletal pain, chills, pyrexia, increased potassium, micturition urgency, and laboratory test abnormalities.
  • WARNINGS include the risk of metastatic bladder cancer if cystectomy is delayed, particularly if high-grade disease persists after a second induction course.
  • ANKTIVA is indicated for intravesical use only and must not be administered via subcutaneous or intravenous routes.