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Early data from two clinical trials show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of the bladder and urinary tract) in patients with low levels of a protein called PD-L1. The data indicate that Keytruda and Tecentriq may not work as well as chemotherapy medicines in this group of patients.
As a result, the European Medicines Agency (EMA) has recommended restricting the use of these medicines as first line-treatments for urothelial cancer.
Keytruda and Tecentriq should now only be used for first-line treatment of urothelial cancer in patients with high levels of PD-L1 (see full indications below).
There are no changes to how these medicines should be used in patients with urothelial cancer who have had chemotherapy or in patients with other cancers for which these medicines are approved.
The two clinical trials are continuing but no new patients with low levels of PD-L1 will be given only Keytruda or Tecentriq. Patients in the trials who have any questions should speak to the doctor treating them.
“Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy advanced or metastatic urothelial carcinoma:
Keytruda is authorised in the EU for urothelial cancer (cancer of the bladder and urinary tract), melanoma (a skin cancer), non-small cell lung cancer and classical Hodgkin lymphoma (a blood cancer); Tecentriq is authorised for urothelial cancer and non small cell lung cancer.
Some cancer cells have a protein (PD-L1) which can attach to a receptor on immune cells (PD-1) and stop the immune cells from attacking them. Keytruda and Tecentriq work in different ways to stop the cancer from disabling the immune cells – Keytruda by targeting PD-1 on immune cells and Tecentriq by targeting PD-L1 on the cancer cells.
“Tecentriq as monotherapy is indicated for the treatment of adult patients with locally
The review of Keytruda started on 3 May 2018 and of Tecentriq on 24 May 2018. Both reviews were carried out as type II variations and were initiated after the marketing authorisation holders informed EMA of the preliminary data from Keynote-361 and IMvigor130.
The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use. The CHMP opinion will be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
