Scintimun: Withdrawal of the marketing authorisation application

SCINTIMUN contains the active substance besilesomab. SCINTIMUN is a white powder to be mixed with a radioactive substance (sodium pertechnetate (^99mTc)), to make up a solution for intravenous injection.

In the European Union, this product has already been authorised in the Czech Republic, Hungary and Sweden, in 1993 and 1994, through national procedures, for similar indications.

SCINTIMUN was to be used in adults to locate an infection or inflammatory lesion and also to detect whether any metastasis is present in bone marrow.

This medicine was to be restricted for administration by healthcare professionals experienced on handling radioactive medicines only.

Besilesomab is a monoclonal antibody (a type of protein that has been designed to recognise and bind to a specific structure called an antigen, that may be found on certain cells in the body). After combination with the radioactive substance and administration, it binds to the antigen present on the surface of a certain type of blood cells, called granulocytes, bringing the radioactivity to them. Those cells accumulate where infection and inflammation occur in the body and also in bone marrow. The radioactive accumulation can therefore be detected in areas of infection or inflammation, using a special camera that reveals the areas of radioactivity, as can the lack of radioactivity in bone marrow occupied by metastases.

The effects of SCINTIMUN were first tested in experimental models before being studied in humans. The company submitted a total of seven studies, involving over 1,000 patients. The design of the main studies essentially focused on the safety and how well the medicine was tolerated by the patient.

Information from scientific publications was presented to support the use of SCINTIMUN in detection of metastases in bone marrow.

The application was at Day 120 when the company withdrew it.

The CHMP had formulated a list of questions to be answered by the company, and the company had not responded to them.

The CHMP normally takes up to 210 days to evaluate a new application. Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the company. Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining question(s) (at day 180). Following CHMP opinion, it usually takes around 2 months for the European Commission to give a licence.

Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that SCINTIMUN could not be approved for diagnostic imaging to determine the location of infectious or inflammatory lesions and to detect metastases in bone marrow.

The studies as they were designed could not generate sufficient evidence of the diagnostic value of SCINTIMUN, and the company is carrying out further work to provide more information on this medicine.

The letter from the company notifying the EMEA of the withdrawal of the application is available under the tab 'All documents'.

The company has informed the CHMP that the ongoing clinical studies of SCINTIMUN will continue until completion.

They will also continue their compassionate use programme (where doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised) where those are available.

If you are being treated, in a clinical trial or in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.

The company will continue to supply this product in the countries where the product is authorised nationally (the Czech Republic, Hungary and Sweden).