Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

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Questions & Answers

On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech’, intended for intended for treating debilitating symptoms of advanced colorectal cancer. The company that applied for authorisation is XBiotech Germany GmbH.

The company requested a re‑examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.

What is Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?

This is a medicine containing the active substance human IgG1 monoclonal antibody specific for human interleukin-1 alpha. It was to be available as a concentrate to be made up into a solution for infusion.

What was the medicine expected to be used for?

The medicine was expected to be used for treating debilitating symptoms of advanced colorectal cancer (cancer of the large intestine). Such symptoms include cachexia, a form of muscle wasting with significant weight loss.

How does the medicine work?

The active substance is a protein that attaches to and blocks the actions of another protein called human interleukin-1 alpha, which is involved in many activities in the body including some that aid the growth and spread of cancer cells. By blocking the actions of human interleukin-1 alpha, the medicine was expected to slow down the growth of the cancer, thus relieving patients’ symptoms.

What did the company present to support its application?

The company presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life. The medicine was compared with placebo (a dummy treatment).

What were the CHMP’s main concerns that led to the refusal?

At the time of the initial review, the CHMP had a number of concerns. Firstly, the study did not show clear improvements in either lean body mass or quality of life. Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care. Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.

During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine. However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine’s benefits and manufacturing controls.

The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.

What consequences does this refusal have for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that it will continue to provide the medicine to all patients currently enrolled in clinical trials or compassionate use programmes.

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

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Key facts

Product details for Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
NameHuman IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
INN or common name

human IgG1 monoclonal antibody specific for human interleukin-1 alpha

Therapeutic area Colorectal Neoplasms
Active substance

human IgG1 monoclonal antibody specific for human interleukin-1 alpha

Date opinion adopted14/09/2017
Company name

XBiotech Germany GmbH

 

StatusNegative
Application typeInitial authorisation