Withdrawal of Application for the EMA Marketing Authorisation of Infigratinib

The European Medicines Agency (EMA) announced on 11 November 2022 that Helsinn Birex Pharmaceuticals Ltd withdrew its application for a marketing authorisation of infigratinib (Febseltiq) for the treatment of cholangiocarcinoma. The company withdrew the application on 11 October 2022.

Febseltiq was developed as a medicine for treating adults with cholangiocarcinoma (cancer of the bile ducts) when the cancer cells have an abnormal form of a receptor called FGFR on their surface.

It was intended for previously treated adults whose cancer could not be removed by surgery and was advanced or had spread to other parts of the body.

Febseltiq contains the active substance infigratinib and was to be available as capsules to be taken orally.

The active substance in Febseltiq, infigratinib, belongs to a group of medicines called protein kinase inhibitors. It works by blocking the activity of FGFRs. Abnormal FGFRs are found on the surface of cancer cells and are involved in the growth and spread of the cancer. By blocking their activity, Febseltiq is expected to reduce the growth and spread of the cancer.

To support its application the company presented results from a study involving 108 patients who had cholangiocarcinoma with abnormal forms of FGFR and who had previously received platinum-based chemotherapy. The study looked at the percentage of patients whose tumour shrank after treatment with Febseltiq. All of the patients took Febseltiq and the medicine was not compared with any other treatment.

The application was withdrawn after the EMA had evaluated the initial information from the company and had prepared questions for the company. The company had not responded to the questions at the time of the withdrawal.

Based on the review of the data, at the time of the withdrawal, the EMA had some concerns and its provisional opinion was that Febseltiq could not have been authorised for the treatment of cholangiocarcinoma.

The EMA noted that the company still needed to show that the medicine’s benefits outweigh its risks. There was insufficient evidence that it works well against tumours, there were a number of severe side effects and there were questions about how the medicine passes through and is metabolised in the body.

As the company was seeking a conditional marketing authorisation, the EMA noted that the requirements for such an authorisation were not met. Finally, the EMA also had some questions about the manufacturing process for the medicine. Therefore, at the time of the withdrawal, the EMA’s opinion was that the benefits of Febseltiq did not outweigh its risks.

In its letter notifying the EMA of the withdrawal of the application, the company stated that it had decided to stop development of the medicine after it had reassessed its regulatory and business strategy.

The company informed the EMA that the ongoing clinical trial with this medicine will be stopped.

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