Pralsetinib (1) – Gavreto®
Non-small cell lung cancer (NSCLC), RET fusion+
Characteristics
| Start date | 15.12.2021 – Marketing authorisation: 18.11.2021 |
|---|---|
| Resolution | 16.06.2022 |
| Limitation date | 31.12.2027 |
| INN | Pralsetinib |
| Brand name | Gavreto® |
| Pharm. company |
Dossier: Roche Pharma AG
New distributor: Blueprint Medicines (Netherlands) B.V. |
| G-BA Procedure ID | D-757 |
| ATC code | L01EX23 Other protein kinase inhibitors (L01EX) |
| 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 | 0.4 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Therapeutic indication of the resolution |
|---|
|
Gavreto is used as monotherapy for the treatment of adult patients with rearranged-through-transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) who have not been previously treated with a RET inhibitor. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with RET fusion-positive, advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50 % of tumour cells; first-line therapy | Pembrolizumab as monotherapy |
| b) | Adults with RET fusion-positive, advanced non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% of tumour cells; first-line therapy. | Cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with nab-paclitaxel or - Pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy (only for patients without EGFR- or ALK-positive tumour mutations and with non-squamous histology) or pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (only with squamous histology) or - monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment) |
| c) | Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC) after first-line therapy with a PD-1/PD-L1 antibody as monotherapy. | Cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with nab-paclitaxel or Monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment) |
| d) | Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC) after first-line therapy with cytotoxic chemotherapy. | Docetaxel (only for patients with PD-L1 negative tumours) or - Pemetrexed (only for patients with PD-L1 negative tumours and except in the case of predominantly squamous histology) or - Nivolumab or - pembrolizumab (only for patients with PD-L1 expressing tumours, PD-L1 tumours, PD-L1 expression ≥ 1 % of tumour cells) or - atezolizumab or - Docetaxel in combination with nintedanib (only for patients with PDL1 negative tumours and adenocarcinoma histology). |
| e) | Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC); after first-line therapy with a PD-1/PD-L1 antibody in combination with platinum-containing chemotherapy or after sequential therapy with a PD-1/PD-L1 antibody and platinum-containing chemotherapy. | Patient-specific therapy with selection of - afatinib - pemetrexed - erlotinib - docetaxel - Docetaxel in combination with ramucirumab - Docetaxel in combination with nintedanib - vinorelbine taking into account previous therapy and histology |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (ARROW) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + ITC (PID/PSM) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Gene/mutation specifics |
- Clinical trials
- To demonstrate the additional benefit of pralsetinib in the treatment of adults with Rearranged-during-Transfection (RET)-fusion-positive, advanced non-small cell lung cancer (NSCLC) who have not previously been treated with a RET inhibitor, the pharmaceutical manufacturer has submitted the results of the ARROW trial.
- ARROW is an ongoing, international, multicentre, single-arm, open-label Phase I/II trial.
- The IMpower132 trial is an international, multicentre, open-label Phase III trial in which adult patients with non-squamous cell NSCLC at stage IV and with an ECOG performance status of 0 or 1, who have not previously received any treatment for their metastatic disease.
a) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% of tumour cells; first-line treatment
- The additional benefit is not proven.
- The results of the submitted single-arm ARROW study alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
- The comparison presented is not suitable for drawing conclusions regarding additional benefit.
- Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.
b) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC) with PD-L1 expression < 50 % of tumour cells; first-line treatment
- An additional benefit is not proven.
- The results of the submitted single-arm ARROW study alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
- The comparison presented is not suitable for drawing conclusions regarding additional benefit.
- Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.
c) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC) following first-line treatment with a PD-1/PD-L1 antibody as monotherapy
- An additional benefit is not proven.
- The results of the submitted single-arm ARROW trial alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
- The comparison presented is not suitable for drawing conclusions regarding additional benefit.
- Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.
d) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC) following first-line treatment with cytotoxic chemotherapy
- The additional benefit is not proven.
- The results of the single-arm ARROW study submitted are not, on their own, suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
- The comparison presented is not suitable for drawing conclusions regarding additional benefit.
- Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.
e) Adults with RET-fusion-positive, advanced non-small cell lung cancer (NSCLC); following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy, or following sequential treatment with a PD-1/PD-L1 antibody and platinum-based chemotherapy
- An additional benefit is not proven.
- The results of the submitted single-arm ARROW study alone are not suitable for assessing the additional benefit of pralsetinib, as they do not allow for a comparison with the appropriate comparator therapy.
- The comparison presented is not suitable for drawing conclusions regarding additional benefit.
- Overall, therefore, there are no suitable data available for assessing the additional benefit of pralsetinib compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Pralsetinib (1) | Gavreto® | Roche Pharma AG | Non-small cell lung cancer (NSCLC), RET fusion+ | 170–510 | 100% additional benefit not proven |
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