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Relugolix (advanced hormone-sensitive prostate cancer)

 

Subject:

  • Active Substance: Relugolix
  • Name: Orgovyx®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Accord Healthcare GmbH

 

Time table:

  • Start: 15.10.2022
  • Publication of assessment: 16.01.2023
  • End of public hearing: 06.02.2023
  • Final decision by G-BA: beginning of April 2023

 

Comparative therapy:

  1. Patients who are eligible for a local therapy:
    • Radical prostatectomy in combination with a lymphadenectomy, if necessary OR
    • percutaneous radiation therapy in combination with conventional androgen deprivation or bicalutamide OR
    • percutaneous radiation therapy in combination with HDR brachytherapy (only for patients in clinical category cT)
  2. Patients who are not eligible for a local therapy:
    • Conventional androgen deprivation OR
    • bicalutamide
  3. Patients with PSA or clinical recurrence after primary local therapy:
    • A patient-individual therapy depending on prior therapies and risk of progression choosing from:
      • salvage prostectomy,
      • percutaneous salvage radiation therapy, and
      • percutaneous salvage radiation therapy in combination with a conventional androgen deprivation or bicalutamide
  4. Patients with metastasized hormone-sensitive prostate cancer (mHSPC):
    • d1. Patients who are eligible for a combination therapy:
      • Conventional androgen deprivation in combination with apalutamide OR
      • Conventional androgen deprivation in combination with abiraterone acetate and prednisone or prednisolone (only for patients with newly diagnosed high risk prostate cancer) OR
      • Conventional androgen deprivation in combination with docetaxel with or without prednisone or prednisolone OR
      • Conventional androgen deprivation in combination with enzalutamide
    • d2. Patients who are not eligible for a combination therapy:
      • Conventional androgen deprivation