following a full submission:
atezolizumab (Tecentriq®) is accepted for use within NHSScotland.
Indication under review: as monotherapy as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the UICC/AJCC staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥50% of tumour cells and whose disease has not progressed following platinum-based adjuvant chemotherapy.
In an open-label, randomised, phase III study, disease-free survival in patients with stage II to IIIA NSCLC, was significantly longer in patients whose tumours had PD-L1 expression on ≥1% of tumour cells and numerically longer in patients whose tumours had PD-L1 expression on ≥50% of tumour cells with atezolizumab compared with best supportive care. All patients prior to randomisation had disease that had not progressed following adjuvant platinum-based chemotherapy, following complete resection.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of atezolizumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
Medicine details
- Medicine name:
- atezolizumab (Tecentriq)
- SMC ID:
- SMC2492
- Indication:
Monotherapy as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the Union for International Cancer Control (UICC)/ American Joint Committee on Cancer (AJCC) - staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥50% of tumour cells (TC) and whose disease has not progressed following platinum-based adjuvant chemotherapy.
- Pharmaceutical company
- Roche
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 08 August 2022
There has been a minor amendment to the wording of the early-stage non-small cell lung cancer (NSCLC) Marketing Authorisation for atezolizumab (Tecentriq), to align with the EU Marketing Authorisation as part of the Windsor Framework. The wording within the Detailed Advice Document has not been amended.
New licensed indication:
As monotherapy as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK-positive NSCLC.
Previous licensed indication:
As monotherapy as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the UICC/AJCC-staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and whose disease has not progressed following platinum-based adjuvant chemotherapy.