EMA Refuses a Change to the Marketing Authorisation for Blinatumomab

It was expected to be used to treat also minimal residual disease in patients with B-precursor ALL
23 Aug 2018
Haematologic malignancies;  Cancer Immunology and Immunotherapy

On 26 July 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for blinatumomab (Blincyto), which is currently used to treat B-precursor acute lymphoblastic leukaemia (ALL). The change concerned an extension of use that would allow the medicine to be used in patients with minimal residual disease after previous treatment. 

The company that applied for the change to the authorisation is Amgen Europe B.V. It may request a re-examination of the opinion within 15 days of receipt of notification of negative opinion. 

Blincyto is a cancer medicine currently used to treat relapsed or refractory Philadelphia chromosome-negative, CD19-positive B-precursor ALL. 

The medicine has been authorised since November 2015 and contains the active substance blinatumomab. 

Blincyto was designated an orphan medicine (a medicine to be used in rare diseases) on 24 July 2009 for ALL. 

What was Blincyto expected to be used for? 

Blincyto was also expected to be used to treat patients with minimal residual disease, which means they have residual cancer cells in their body after previous treatment with other medicines and could therefore be at higher risk of B-precursor ALL returning. 

In B-precursor ALL, certain cells that give rise to B cells multiply too quickly and eventually these abnormal cells replace normal blood cells. 

The active substance in Blincyto, blinatumomab, is an antibody that has been designed to recognise and attach to CD19 found on all B cells, including ALL cells. It also attaches to CD3 found on T cells. Blincyto therefore acts as a bridge, bringing the T cells and the B cells together and causing the activation of T cells, which release substances that eventually kill B cells. 

What did the company present to support its application? 

The company presented data from a main study in 116 patients with residual cancer cells who were treated with Blincyto. The study did not compare Blincyto with any other treatment. It looked at how many patients no longer had residual disease after one treatment cycle. 

What were the CHMP’s main concerns that led to the refusal of the change to the marketing authorisation? 

The CHMP noted that although Blincyto helped clear away residual cells in many patients, there is no strong evidence that it leads to improved survival in patients. Given the uncertainty, the CHMP was of the opinion that the benefits of Blincyto in patients with residual B-precursor ALL cells did not outweigh its risks. The CHMP therefore recommended that the change to the marketing authorisation be refused. 

The company informed the CHMP that there are no consequences for patients in clinical trials. 

There are no consequences for Blincyto in its authorised use.

Last update: 23 Aug 2018

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