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Withdrawal of Application for a Change to the EU Marketing Authorisation for Atezolizumab

It was also expected to be used in combination with bevacizumab to treat advanced or metastatic RCC
10 Dec 2018
Genitourinary cancers;  Cancer Immunology and Immunotherapy

On 22 October 2018, Roche Registration GmbH officially notified the European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for atezolizumab (Tecentriq) to extend its use for treating renal cell carcinoma (RCC). 

Tecentriq is a cancer medicine already authorised for treating urothelial carcinoma and non-small cell lung cancer. It contains the active substance atezolizumab and has been authorised since September 2017. Further information on Tecentriq’s current uses can be found on the Agency’s website

Tecentriq was also expected to be used in combination with another medicine, bevacizumab to treat advanced or metastatic RCC. The intended patients were to have high levels of PD-L1. 

The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, designed to recognise and attach to PD-L1, which is present on the surface of many cancer cells. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD-L1 and reducing its effects, Tecentriq increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease. 

To support its application, the company presented data from a main study in 915 patients which compared Tecentriq plus bevacizumab with the cancer medicine sunitinib. The study looked at overall and progression-free survival. 

The application was withdrawn while CHMP was still evaluating the initial documentation provided by the company. As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations. 

In its letter notifying the Agency of the withdrawal of application, the company stated that results from the main study were not sufficient to support a new use at present. 

The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tecentriq. 

This withdrawal has no consequences on the medicine’s currently authorised uses.

Last update: 10 Dec 2018

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