Dossier assessment
Relugolix (prostate cancer) – Benefit assessment acc. to § 35a Social Code Book V
Report documents
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Extract of dossier assessment
Relugolix (prostate cancer) – Benefit assessment acc. to § 35a Social Code Book V
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Dossier assessment
Relugolix (prostate cancer) – Benefit assessment acc. to § 35a Social Code Book V
Dossier assessment
Indication:
Patients with hormone-sensitive prostate cancer
Result of dossier assessment:
- Patients with advanced hormone-sensitive prostate cancer who are candidates for local therapy: added benefit not proven
- Patients with advanced hormone-sensitive prostate cancer who are not candidates for local therapy: added benefit not proven
- Patients with advanced hormone-sensitive prostate cancer and with PSA recurrence or clinical recurrence after primary local therapy: added benefit not proven
- Patients with metastatic hormone-sensitive prostate cancer who are candidates for combination therapy: added benefit not proven
- Patients with metastatic hormone-sensitive prostate cancer who are not candidates for combination therapy: added benefit not proven
Additional information
Federal Joint Committee (G-BA)
2023-04-06 A G-BA decision was published.
Project details
- Project no.
- A22-108
- Commission
- Commission awarded on 17.10.2022 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Cancer
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.
The current version 1.1 of the dossier assessment replaces version 1.0 published on 2023-01-16.