[A19-90] Larotrectinib (solid tumours) - Benefit assessment according to §35a Social Code Book V

Last updated 15.01.2020

Project no.:
A19-90

Commission:
Commission awarded on 15.10.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Patients with solid tumours that display an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options

Result of dossier assessment:

Added benefit not proven due to lack of suitable study data

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.

15.01.2020

Larotrectinib in tumours with NTRK gene fusion: Data are not yet sufficient for derivation of an added benefit

First assessment of a histology-independent drug / studies without control arms

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

Federal Joint Committee (G-BA)

2020-04-02 A G-BA decision was published.

G-BA documents on this decision

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