Lorlatinib (1) – Lorviqua®
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
Characteristics
| Start date | 01.06.2019 – Marketing authorisation: 06.05.2019 |
|---|---|
| Resolution | 22.11.2019 |
| INN | Lorlatinib |
| Brand name | Lorviqua® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-451 |
| ATC code | L01ED05 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 | 0.1 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after: - alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or - crizotinib and at least one other ALK TKI. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Patients with ALK-positive, advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK-TKI therapy or crizotinib and at least one other ALK-TKI; for whom further antineoplastic systemic therapy is an option | Patient-specific therapy taking into account the ALK inhibitors alectinib and ceritinib as well as combination or mono-chemotherapies |
| b) | Patients with ALK-positive, advanced NSCLC whose disease has progressed after alectinib or ceritinib as first ALK-TKI therapy or crizotinib and at least one other ALK-TKI; for whom further antineoplastic systemic therapy is not an option. | Best-Supportive-Care |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (B7461001) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility |
- Clinical trials
- To demonstrate the additional benefit, the pharmaceutical manufacturer has drawn on data from the international, multicentre, open-label Phase I/II registration trial B7461001.
a) Patients with ALK-positive, advanced NSCLC whose disease has progressed following treatment with alectinib or ceritinib as first-line ALK-TKI therapy, or with crizotinib and at least one other ALK-TKI; for whom further systemic antineoplastic therapy is an option
- An additional benefit is not proven
- The pharmaceutical manufacturer does not present any results in the dossier from directly comparative studies or studies suitable for an adjusted indirect comparison. Based on this evidence, it is not possible to infer any additional benefit for the two patient populations.
- The additional benefit of lorlatinib in the treatment of patients with ALK-positive, advanced NSCLC whose disease has progressed following alectinib or ceritinib as first-line ALK-TKI therapy, or crizotinib and at least one other ALK-TKI; whether or not they are eligible for further systemic antineoplastic therapy, is not proven.
b) Patients with ALK-positive, advanced NSCLC whose disease has progressed following treatment with alectinib or ceritinib as first-line ALK-TKI therapy, or with crizotinib and at least one other ALK-TKI; for whom further antineoplastic systemic therapy is not an option
- An additional benefit is not proven
- The pharmaceutical manufacturer does not present any results in the dossier from direct comparative studies or studies suitable for an adjusted indirect comparison. On the basis of this data, it is not possible to infer any additional benefit for the two patient populations.
- The additional benefit of lorlatinib in the treatment of patients with ALK-positive, advanced NSCLC whose disease has progressed following alectinib or ceritinib as first-line ALK-TKI therapy, or crizotinib and at least one other ALK-TKI; for whom further systemic antineoplastic therapy is an option or for whom further systemic antineoplastic therapy is not an option, it is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Lorlatinib (2) | Lorviqua® | Pfizer Pharma GmbH | Non-small cell lung cancer (NSCLC), ALK+, first-line | 390–1,310 | 100% additional benefit not proven | |
| Lorlatinib (1) | Lorviqua® | Pfizer Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated | 200–1,310 | 100% additional benefit not proven |
<< List of all resolutions