Posted by Michael Wonder on 24 Aug 2022
Roche withdraws application for Tecentriq
25 August 2022 - Publication of AusPAR reveals the withdrawal of the application in July 2021.
Roche sought the approval of atezolizumab (Tecentriq) for use as monotherapy for the first-line treatment of patients with metastatic non-small-cell lung cancer whose tumours have a PD-L1 expression ≥ 50% tumour cells or ≥ 10% tumour-infiltrating immune cells and who do not have EGFR or ALK genomic tumour aberrations.
The Advisory Committee on Medicines concluded that atezolizumab had an overall negative benefit-risk profile for the proposed indication as the evidence submitted did not satisfactorily establish the quality and safety of the product for the proposed usage.
