Dossier assessment

Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

Report documents

Indication:

Adults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease

Result of dossier assessment:

Clear advantages in symptomatic progression, disadvantages in some side effects; indication of considerable added benefit

02.05.2019

Study shows significant retardation of symptomatic progression

2019-08-01 A G-BA decision was published.

Project no.: A19-09
Commission: Commission awarded on 24.01.2019 by the Federal Joint Committee (GBA).
Report type: Dossier assessment
Status: Commission completed
Department/Division: Drug Assessment
Topic: Cancer
Note: After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.

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