On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tecentriq. The marketing authorisation holder for this medicinal product is Roche Registration GmbH.
“Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):
- after prior platinum‑containing chemotherapy, or
- who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non‑small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC ) after prior chemotherapy. Patients with EGFR activating mutationsmutant or ALK‑positive tumour mutationsNSCLC should also have received targeted therap yies before receiving Tecentriq (see section 5.1).”
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
* New text in bold, removed text as strikethrough
|Agency product number||
|International non-proprietary name (INN) or common name||
Carcinoma, Transitional Cell
Carcinoma, Non-Small-Cell Lung
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
|Date opinion adopted||
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 201816/11/2018