Ceritinib (3) – Zykadia®
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
Characteristics
| Start date | 01.08.2017 – Marketing authorisation: 23.06.2017 |
|---|---|
| Resolution | 01.02.2018 |
| INN | Ceritinib |
| Brand name | Zykadia® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-296 |
| ATC code | L01ED02 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 | 0.45 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients for first-line treatment of advanced, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC). | Crizotinib |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (ASCEND-4) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (Bucher) |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 20.06.2017 – Zulassungsänderung nach positive Opinion (EMA) |
- Clinical trials
- The ASCEND-4 trial is the registration trial for ceritinib in this therapeutic indication. It is the only randomised, actively controlled, open-label trial (RCT) with ceritinib in this therapeutic indication.
- The ASCEND-4 trial enrolled previously untreated adult patients with ALK-positive NSCLC at a locally advanced or metastatic stage (stage IIIB or IV). Patients received either treatment with ceritinib or with platinum-based combination chemotherapy comprising cisplatin in combination with pemetrexed or carboplatin in combination with pemetrexed.
- With regard to crizotinib in comparison with this bridging comparator, the pharmaceutical manufacturer identifies the two studies PROFILE 1014 and PROFILE 1029.
- These studies were all randomised, actively controlled, open-label trials. The studies included previously untreated adult patients with ALK-positive NSCLC at a locally advanced or metastatic stage.
a) Adult patients for first-line treatment of advanced, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC)
- For first-line treatment of patients with advanced, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), an additional benefit over the appropriate comparator therapy is not proven.
- In the absence of available RCTs, the pharmaceutical manufacturer identified three studies relevant to an indirect comparison of ceritinib and crizotinib.
- The studies identified by the pharmaceutical manufacturer – ASCEND-4, PROFILE 1014 and PROFILE 1029, identified by the pharmaceutical company, are not suitable for an indirect comparison due to the lack of comparability of the bridging comparator, and therefore cannot be used to draw conclusions regarding the additional benefit of ceritinib compared with the appropriate comparator therapy.
- As there are no relevant data available overall for assessing the additional benefit of ceritinib, the additional benefit is not proven.
- Overall assessment / Conclusion
- Due to differences in the bridging comparator, the studies ASCEND-4, PROFILE 1014 and PROFILE 1029 identified by the pharmaceutical manufacturer are not suitable for an indirect comparison.
- As there are no relevant data available overall to assess the additional benefit of ceritinib, the additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Ceritinib (3) | Zykadia® | Novartis Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, first-line | 430–850 | 100% additional benefit not proven | |
| Ceritinib (2) | Zykadia® | Novartis Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib | 200–1,310 | 81% Hint for considerable additional benefit | |
| Ceritinib (1) | Zykadia® | Novartis Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib |
0
120–560 |
100% additional benefit not proven repealed |
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