Brigatinib (1) – Alunbrig®
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
Characteristics
| Start date | 15.01.2019 – Marketing authorisation: 22.11.2018 |
|---|---|
| Resolution | 04.07.2019 |
| INN | Brigatinib |
| Brand name | Alunbrig® |
| Pharm. company | Takeda GmbH |
| G-BA Procedure ID | D-434 |
| ATC code | L01ED04 ALK inhibitors (L01ED) |
| ICD-10 codes (AIS) | C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung |
| Alpha-ID codes (AIS) | I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas |
| DDD | 0.18 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Monotherapy indicated in adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib | Ceritinib or alectinib |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (ALTA und ASCEND-5) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (MAIC) |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 24.06.2019 – nach Dossiereinreichung, Stellungnahmeverfahren |
- Clinical trials
- The ALTA trial was a two-arm, open-label, phase II randomised controlled trial (RCT) that enrolled patients with crizotinib-pretreated, ALK-positive, locally advanced or metastatic NSCLC; prior treatment with chemotherapy was also permitted.
- The ASCEND-5 trial is a two-arm, open-label, phase IIIRCT that enrolled patients with ALK-positive, locally advanced or metastatic NSCLC who, according to the inclusion criteria, had to have previously been treated with crizotinib and one or two courses of chemotherapy (including ≥ 1 platinum-based chemotherapy).
- The AP26113-11-101 is a non-randomised, uncontrolled dose-finding study of brigatinib involving 137 adult patients with various tumour types, 25 of whom fall within the current therapeutic indication and who received brigatinib at the authorised dose.
- The ALTA-1L study is an open-label RCT directly comparing brigatinib with crizotinib in patients with ALK-positive, locally advanced or metastatic NSCLC who had not previously been treated with a tyrosine kinase inhibitor.
a) Adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC) who have previously been treated with crizotinib
- The additional benefit is not proven.
- As there are no data available to enable an assessment of additional benefit, additional benefit is not proven for brigatinib as monotherapy in the treatment of adult patients with ALK-positive, advanced NSCLC who have previously been treated with crizotinib.
Courtesy translation only, please refer to the German original.
Associated procedures
| Brigatinib (2) | Alunbrig® | Takeda GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients | 420–910 | 50% Hint for considerable additional benefit | |
| Brigatinib (1) | Alunbrig® | Takeda GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib | 160–1,060 | 100% additional benefit not proven |
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