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EMA Restricts Use of Pembrolizumab and Atezolizumab in Bladder Cancer

Data show lower survival in some patients with low PD-L1 levels
08 Jun 2018
Genitourinary Cancers

Early data from two clinical trials (Keynote-361 and IMvigor130) show reduced survival with pembrolizumab (Keytruda) and atezolizumab (Tecentriq) when used as first-line treatments for urothelial cancer in patients with low expressions of PD-L1. The data indicate that Keytruda and Tecentriq may not work as well as chemotherapy 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.

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.

The review of data on Keytruda and Tecentriq was carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP).

Preliminary data from Keynote-361 and IMvigor130 show a reduced survival with Keytruda and Tecentriq compared with chemotherapy in patients with locally advanced or metastatic urothelial cancer who have not received prior therapy and whose tumours have low expressions of PD-L1.

Based on the data from the trials, which are still ongoing, the urothelial cancer indications for Keytruda and Tecentriq are being revised as follows:


Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥10.


Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma:

  • after prior platinum‑containing chemotherapy, or
  • who are considered cisplatin ineligible, and whose tumours have a PD-L1expression ≥5%.

Healthcare professionals in the EU will be sent a letter with details of these recommendations and the two ongoing studies.

Keytruda is authorised in the EU for urothelial cancer, melanoma, non-small cell lung cancer and classical Hodgkin lymphoma; 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 PD-1 receptor on immune cells 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.

More about the procedure

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 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.

Last update: 08 Jun 2018

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