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Withdrawal of Application to Change the Marketing Authorisation for Atezolizumab

Withdrawal concerns the application to extend the use of atezolizumab to include the treatment of early or locally advanced triple-negative breast cancer
26 Jul 2021
Breast cancer;  Cancer Immunology and Immunotherapy

The European Medicines Agency (EMA) informed on 23 July 2021 that Roche Registration GmbH withdrew its application for the use of atezolizumab (Tecentriq) to treat early or locally advanced triple-negative breast cancer (TNBC).

The company withdrew the application on 23 June 2021.

Tecentriq is a cancer medicine for treating urothelial cancer, lung cancer, hepatocellular carcinoma, and TNBC.

Tecentriq has been authorised in the EU since September 2017. It contains the active substance atezolizumab and is given intravenously. Further information on Tecentriq’s uses can be found on the Agency’s website.

The company applied to extend the use of Tecentriq in treating TNBC. Currently Tecentriq is used with nab-paclitaxel when the cancer cannot be removed by surgery. The company also wanted Tecentriq to be used before surgery in patients with early or locally advanced TNBC in combination with nab-paclitaxel and anthracycline-based chemotherapy.

The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, designed to recognise and attach to PD-L1, which is present on many 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 progression of the disease.

To support its application, the company presented data from an ongoing main study of 333 patients who received either Tecentriq or placebo in combination with nab-paclitaxel and anthracycline-based chemotherapy, before going on to have surgery. The main measure of effectiveness was how many patients no longer had tumours in their breasts or lymph nodes after surgery. Patients were followed-up afterwards to assess longer-term benefits and to see if their cancer recurred.

The application was withdrawn after the EMA had evaluated the information from the company and had prepared questions for the company. After the Agency had assessed the company’s responses to the questions, there were still some unresolved issues.

Based on the review of the information and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that the use of Tecentriq could not be extended. The Agency noted that the effect of Tecentriq in the main study was not sufficient to establish that the medicine worked well enough when given with other medicines before surgery for TNBC. Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Tecentriq did not outweigh its risks in the treatment of early or locally advanced TNBC before surgery in combination with nab-paclitaxel and anthracycline-based chemotherapy.

In its letter notifying the Agency of the withdrawal of application, the company stated it withdrew the application because data from the main study did not allow the EMA’s Committee for Medicinal Products for Human Use to conclude that the benefit-risk balance was positive.

There are no consequences for patients who are receiving Tecentriq in clinical trials. There are no consequences on the use of Tecentriq in its existing uses.

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