Crizotinib (4) – Xalkori®
Non-small cell lung carcinoma (NSCLC), ROS1+
Characteristics
| Start date | 01.10.2016 – Marketing authorisation: 25.08.2016 |
|---|---|
| Resolution | 16.03.2017 |
| INN | Crizotinib |
| Brand name | Xalkori® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-261 |
| ATC code | L01ED01 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 | 0.5 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
XALKORI as monotherapy is indicated for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| 1) | Treatment of ROS1-positive advanced non-small cell lung cancer: non-pretreated patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). | Patients with ECOG performance status 0, 1 or 2: (cisplatin in combination with a third-generation cytostatic) or (carboplatin in combination with a third-generation cytostatic), patients with ECOG performance status 2: monotherapy with gemcitabine or vinorelbine. |
| 2a) | Treatment of ROS1-positive advanced non-small cell lung cancer: pre-treated patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) who are eligible for treatment with docetaxel or pemetrexed. | Docetaxel or pemetrexed |
| 2b) | Treatment of ROS1-positive advanced non-small cell lung cancer: pre-treated patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) for whom treatment with docetaxel or pemetrexed is not an option. | Best-Supportive-Care |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (Bergethon 2012, Gainor 2013) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Patient eligibility |
- Clinical trials
- Both RCTs compare crizotinib with chemotherapy in previously untreated (PROFILE1014) and previously treated (PROFILE1007) patients with ALK-positive advanced NSCLC and have already been assessed for these patients.
1) previously untreated patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC)
- For previously untreated patients with ROS1-positive, advanced non-small cell lung cancer and previously treated patients with ROS1-positive, advanced non-small cell lung cancer who are eligible for treatment with docetaxel or pemetrexed, an additional benefit over the appropriate comparator therapy is not proven.
- There are no randomised controlled trials (RCTs) involving patients with ROS1-positive advanced NSCLC that directly compare crizotinib with the appropriate comparator therapy.
- Overall, there are no data available that would allow an assessment of the additional benefit of crizotinib compared with the appropriate comparator therapy. The additional benefit is not proven.
2a) Previously treated patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) – patients for whom treatment with docetaxel or pemetrexed is an option
- For previously untreated patients with ROS1-positive, advanced non-small cell lung cancer and previously treated patients with ROS1-positive, advanced non-small cell lung cancer, for whom treatment with docetaxel or pemetrexed is an option, an additional benefit over the appropriate comparator therapy is not proven.
- There are no randomised controlled trials (RCTs) involving patients with ROS1-positive advanced NSCLC that directly compare crizotinib with the appropriate comparator therapy.
- Overall, there are no data available that would allow an assessment of the additional benefit of crizotinib compared with the appropriate comparator therapy. The additional benefit is not proven.
2b) Pre-treated patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) – patients for whom treatment with docetaxel or pemetrexed is not an option
- For previously treated patients with ROS1-positive, advanced non-small cell lung cancer for whom treatment with docetaxel or pemetrexed is not an option, an additional benefit is not proven compared with the appropriate comparator therapy.
- The pharmaceutical manufacturer has not submitted any data on this issue.
Courtesy translation only, please refer to the German original.
Associated procedures
| Crizotinib (4) | Xalkori® | Pfizer Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ROS1+ | 210–770 | 100% additional benefit not proven | |
| Crizotinib (3) | Xalkori® | Pfizer Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated | 480 | 71% Hint for considerable additional benefit | |
| Crizotinib (2) | Xalkori® | Pfizer Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, first-line |
0
300–900 |
100% Hint for considerable additional benefit repealed | |
| Crizotinib (1) | Xalkori® | Pfizer Pharma GmbH | Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated |
0
480 |
71% Hint for considerable additional benefit repealed |
<< List of all resolutions