Withdrawal of Application to Change the EU Marketing Authorisation for Pembrolizumab

New use was intended in the treatment of oesophageal cancer
04 Feb 2020

The European Medicines Agency (EMA) announced on 31 January 2020 that Merck Sharp & Dohme B.V. withdrew its application for the use of pembrolizumab (Keytruda) in the treatment of oesophageal cancer. The company withdrew its application on 10 December 2019.

Keytruda is a medicine already used to treat several cancers: melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, urothelial cancer, head and neck squamous cell carcinoma and renal cell carcinoma. Further information on Keytruda’s uses can be found on the Agency’s website.

The company applied to add to the medicine’s authorised uses the treatment of relapsed/recurrent locally advanced or metastatic oesophageal cancer.

The medicine was to be used in patients whose tumours produce high levels of PD-L1 and who had previously been treated with other cancer medicines. In the treatment of oesophageal cancer, Keytruda is expected to work in the same way as it does in its existing uses. The active substance in Keytruda, pembrolizumab, is a monoclonal antibody that has been designed to block a PD-1 receptor.

To support its application, the company presented that Keytruda was investigated in a main study involving 628 patients with advanced or metastatic oesophageal cancer. Keytruda was compared with other cancer treatments (paclitaxel, docetaxel, or irinotecan). The main measure of effectiveness was patients’ overall survival (OS).

The application was withdrawn after the EMA had evaluated the information from the company and had prepared questions for the company.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 Keytruda could not have been authorised for oesophageal cancer. The Agency considered that the results from the study did not show that Keytruda was effective at prolonging the OS in patients with oesophageal cancer. Therefore, at the time of the withdrawal, the Agency’s opinion was that the balance of benefits and risks of Keytruda in the treatment of oesophageal cancer could not be established.

In its letter notifying the Agency of the withdrawal of application, the company stated that it is withdrawing the application because the results of the study were not considered sufficient to support an extension of indication at this time.

The company informed the Agency that there are no consequences for patients who are receiving Keytruda for the treatment of oesophageal cancer in clinical trials.

There are no consequences for Keytruda in its authorised uses.

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