[A21-89] Nivolumab (malignant pleural mesothelioma) - Benefit assessment according to §35a Social Code Book V

Last updated 01.10.2021

Project no.:
A21-89

Commission:
Commission awarded on 01.07.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

First-line treatment of unresectable malignant pleural mesothelioma in adults

Result of dossier assessment:

  • Patients with epithelioid tumour histology: added benefit not proven.
  • Patients with non-epithelioid tumour histology: indication of considerable added benefit.

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.

01.10.2021

Nivolumab + ipilimumab: added benefit in pleural mesothelioma with non-epithelioid tumour histology

For the first time, a pure antibody combination is approved as first-line therapy for unresectable malignant pleural mesothelioma...

Project no. Title Status
A21-59 Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-39 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A20-121 Nivolumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A20-118 Nivolumab (non-small cell lung cancer, combination with ipilimumab) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-11 Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-53 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-40 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A17-29 Nivolumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-27 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A17-24 Nivolumab (squamous cell carcinoma of the head and neck) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-76 Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-35 Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-57 Nivolumab (NSCLC) - Addendum to Commission A16-25 Commission completed
A16-24 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V Commission completed
A15-32 Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Commission completed
A15-27 Nivolumab – Benefit assessment according to §35a Social Code Book V (dossier assessment) Commission completed
A21-141 Nivolumab (malignant pleural mesothelioma) - Addendum to Commission A21-89 Commission completed

Federal Joint Committee (G-BA)

2021-12-16 A G-BA decision was published.

G-BA documents on this decision

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