Osimertinib (7) – Tagrisso®
Non-small cell lung cancer, EGFR mutations, after platinum-based radiochemotherapy
Characteristics
| Start date | 15.01.2025 – Marketing authorisation: 19.12.2024 |
|---|---|
| Resolution | 03.07.2025 |
| INN | Osimertinib |
| Brand name | Tagrisso® |
| Pharm. company |
Dossier: AstraZeneca GmbH
New distributor: AstraZeneca GmbH GB Spezialvertrieb |
| G-BA Procedure ID | D-1142 |
| ATC code | L01EB04 EGFR tyrosine kinase inhibitors (L01EB) |
| ICD-10 codes (AIS) | C33Malignant neoplasm of trachea, 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) | I107749Malignant neoplasm of the trachea, I116362Bronchial carcinoma of the main bronchus, I116693Non-small cell lung cancer, I30011Malignant neoplasm of the upper lobe of the lung, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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|
Tagrisso is indicated as monotherapy for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR mutations as deletion in exon 19 or substitution mutation in exon 21 (L858R) and whose disease has not progressed during or after platinum-containing radiochemotherapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with locally advanced, unresectable NSCLC whose tumours have EGFR mutations as deletion in exon 19 or substitution mutation in exon 21 (L858R), whose disease has not progressed during or after platinum-containing radiochemotherapy and whose tumours express PD-L1 in ≥ 1% of tumour cells | Durvalumab |
| b) | Adults with locally advanced, unresectable NSCLC whose tumours have EGFR mutations as deletion in exon 19 or substitution mutation in exon 21 (L858R), whose disease has not progressed during or after platinum-containing radiochemotherapy and whose tumours express PD-L1 in < 1% of tumour cells | Best Supportive Care |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (LAURA) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
- Clinical trials
- The LAURA trial is an ongoing, double-blind, randomised, controlled trial comparing osimertinib with placebo.
a) Adults with locally advanced, inoperable NSCLC whose tumours harbour EGFR mutations in the form of a deletion in exon 19 or a substitution mutation in exon 21 (L858R), whose disease has not progressed during or after platinum-based chemoradiotherapy, and whose tumours express PD-L1 in ≥ 1% of tumour cells
- The additional benefit is not proven.
- The definition of the appropriate comparator therapy results in patient groups that differ depending on the patients’ PD-L1 status. However, PD-L1 status was not assessed in the LAURA study. Consequently, the study population cannot be assigned to patient groups a) and b).
- Overall, there are no suitable data available to assess the additional benefit of osimertinib for patient group a). The additional benefit is therefore not proven.
b) Adults with locally advanced, inoperable NSCLC whose tumours harbour EGFR mutations in the form of a deletion in exon 19 or a substitution mutation in exon 21 (L858R), whose disease has not progressed during or after platinum-based chemoradiotherapy, and whose tumours express PD-L1 in < 1 % of tumour cells
- The additional benefit is not proven.
- The definition of the appropriate comparator therapy results in patient groups that differ depending on the patients’ PD-L1 status. However, PD-L1 status was not assessed in the LAURA study. Consequently, the study population cannot be assigned to patient groups a) and b).
- Overall, there are no suitable data available to assess the additional benefit of osimertinib for patient group b). The additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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