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FDA Press Releases·

FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer

  • The FDA expanded Anktiva's approved use to include adults with high-grade papillary-only bladder cancer that has not spread to the muscle layer & failed BCG treatment.
  • This approval marks the first FDA-approved treatment specifically for BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer.
  • The decision was based on scientific similarities between papillary-only disease & carcinoma in situ (CIS), leveraging evidence from Anktiva's prior CIS approval.
  • Anktiva is administered with BCG directly into the bladder once weekly for six weeks, with treatment potentially continuing up to 37 months based on response.
  • Common side effects include painful urination, urinary tract infections, chills, fever, & elevated creatinine or potassium levels.
  • The prescribing information warns that delaying bladder removal surgery may allow cancer to spread & become fatal.
  • The approval was granted to Altor BioScience, LLC.
  • The FDA is finalizing draft guidance to help developers use CIS study data to support future approvals for similar BCG-unresponsive conditions.