Withdrawal of the Application to Change the EMA Marketing Authorisation for Pralsetinib

The European Medicines Agency (EMA) announced on 11 November 2022 that Roche Registration GmbH withdrew its application for the use of pralsetinib (Gavreto) in certain types of thyroid cancer. The company withdrew the application on 3 November 2022.

Gavreto is a cancer medicine used to treat adults with advanced non-small cell lung cancer (NSCLC) caused by changes in a gene called RET (known as RET fusion-positive NSCLC) and who have not been treated with a RET inhibitor.

Gavreto has been authorised in the EU since November 2021.

It contains the active substance pralsetinib and is available as capsules.

Further information on Gavreto’s current uses can be found here.

The company applied to extend the use of Gavreto to treat patients from 12 years of age who have RET-mutated medullary thyroid cancer or RET fusion-positive thyroid cancer. It was intended for patients who had received previous treatments but not with a RET inhibitor, and whose cancer was advanced or had spread to other parts of the body.

In thyroid cancer caused by changes in the RET protein, Gavreto is expected to work in the same way as it does in its existing indication. The active substance in Gavreto, pralsetinib, is a RET inhibitor, which belongs to a broader class of cancer medicines known as tyrosine kinase inhibitors. It blocks the activity of the abnormal RET protein, which causes uncontrolled cell growth and cancer. By blocking the abnormal RET, pralsetinib helps to reduce the growth and spread of the cancer.

To support its application the company presented the results from a trial including 172 patients with RET-mutated medullary thyroid cancer or RET fusion-positive thyroid cancer who all received Gavreto. The main measure of effectiveness was the proportion of patients whose cancer responded to treatment.

The application was withdrawn after the EMA had evaluated the information from the company and had prepared questions for the company. After the EMA 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 EMA’s questions, at the time of the withdrawal, the EMA had some concerns and its provisional opinion was that Gavreto could not have been authorised for the treatment of patients from 12 years of age with RET-mutated medullary thyroid cancer or RET fusion-positive thyroid cancer. The EMA considered that the company did not provide adequate data to support the use of Gavreto in adolescents.

In its letter notifying the EMA of the withdrawal of application, the company stated that it withdrew its application because of a change in its strategy.

The company informed the EMA that there are no consequences for patients in clinical trials using Gavreto.

There are no consequences on the use of Gavreto in NSCLC.