Αρχική World News Withdrawal of Application to Change the Marketing Authorisation for Atezolizumab

Withdrawal of Application to Change the Marketing Authorisation for Atezolizumab

The European Medicines Agency (EMA) announced on 29 January 2021 that Roche Registration GmbH withdrew its application for the use of atezolizumab (Tecentriq) to treat metastatic urothelial cancer in combination with platinum-based therapy in patients who had not been treated before. The company withdrew the application on 8 January 2021.

Tecentriq is already used to treat urothelial cancer, lung cancer, triple-negative breast cancer, and hepatocellular carcinoma. For urothelial cancer, Tecentriq is used on its own in patients who had already received platinum-based chemotherapy or in patients who cannot receive platinum-based therapy and whose cancer cells have a certain amount of PD-L1. Tecentriq has been authorised in the EU since September 2017. The company applied to extend the use of Tecentriq so it can be used in combination with platinum-based chemotherapy as a first-line treatment for advanced or metastatic urothelial cancer.

Tecentriq contains the active substance atezolizumab and is given as an infusion into a vein. Atezolizumab, is a monoclonal antibody designed to recognise and attach to PD-L1, which is present on 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 progression of the disease.

To support its application, the company presented data from a main study in around 1,200 patients with advanced or metastatic urothelial cancer who had not been treated before. Patients received either Tecentriq plus gemcitabine in combination with carboplatin or cisplatin (both platinum therapies); placebo plus gemcitabine in combination with carboplatin or cisplatin; or Tecentriq alone. The study looked at progression-free survival and overall survival.

The application was withdrawn after the EMA had evaluated the initial information from the company and had prepared questions for the company.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 Tecentriq could not have been authorised for the first-line treatment of patients with urothelial cancer in combination with cisplatin.

The Agency noted that the main study could not show that Tecentriq was effective as the different types of patients involved and treatments used made interpreting the results difficult. Data on progression-free survival were not conclusive and those on survival were not statistically significant.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Tecentriq in the first-line treatment of urothelial cancer did not outweigh its risks.

In its letter notifying the Agency of the withdrawal of application, the company stated that it withdrew its application because the Agency could not conclude on a positive benefit-risk balance based on the data provided.

The company informed the Agency that this withdrawal has no consequences for patients in clinical trials using Tecentriq.

Source

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