Roche pulls Tecentriq from US market in bladder cancer indication

Swiss pharma giant Roche (ROG: SIX) has announced the voluntary withdrawal of a US indication for Tecentriq (atezolizumab), its blockbuster immuno-oncology drug.

The impacted indication is in adults with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1–stained tumor-infiltrating immune cells covering at least 5% of the tumor area or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

Roche made the decision following consultation with the US Food and Drug Administration (FDA), in accordance with the requirements of the agency’s Accelerated Approval Program, because Tecentriq had failed to show the benefit required to justify its continued approval in an obligatory trial.