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European Medicines Agency Refuses a Change to the Marketing Authorisation for Vinflunine

The change concerned an extension of indication to add treatment of breast cancer
03 Oct 2014
Anticancer agents & Biologic therapy

On 25 September 2014, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product vinflunine (Javlor). The change concerned an extension of indication to add treatment of breast cancer.

The company that applied for the change to the authorisation is Pierre Fabre Médicament. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

What is vinflunine?

Vinflunine is a cancer medicine that has been authorised in the EU since September 2009. It is already used to treat adults with advanced or metastatic transitional-cell carcinoma of the urothelial tract. Javlor contains the active substance vinflunine and is available as a concentrate for solution for intravenous infusion. 

What was vinflunine expected to be used for?

Vinflunine was also expected to be used in combination with capecitabine for the treatment of adult patients with locally-advanced or metastatic breast cancer. It was to be used in patients previously treated with or resistant to an anthracycline and who are also resistant to taxanes.

How is vinflunine expected to work?

The active substance in Javlor, vinflunine, belongs to the group of cancer medicines known as vinca alkaloids. It attaches to a cell protein called tubulin, which is important in the formation of the internal skeleton that cells need to allow them to divide. By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.

What did the company present to support its application?

The company presented the results of a main study involving 770 patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant. In the study, vinflunine given together with capecitabine was compared with capecitabine alone. The main measure of effectiveness was progression-free survival.

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

The CHMP noted that the effectiveness of vinflunine in combination with capecitabine had not been sufficiently demonstrated. Although there was an improvement in progression-free survival, this was considered to be small. In addition, there was no benefit in terms of other important measures of effectiveness, including overall survival. 

Compared with patients given capecitabine alone, more patients receiving vinflunine plus capecitabine experienced side effects including neutropenia, gastrointestinal events such as constipation, nausea and vomiting and stomach ache, fatigue and nervous system disorders such as peripheral neuropathy.

Therefore, at that point in time, the CHMP was of the opinion that the modest effect of vinflunine in the treatment of breast cancer did not outweigh the additional risks observed. Hence, the CHMP recommended that the change to the marketing authorisation be refused.

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

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

What is happening with vinflunine for the treatment of transitional-cell carcinoma of the urothelial tract?

There are no consequences on the use of vinflunine in its authorised indication. The full European Public Assessment Report for vinflunine can be found on the Agency’s website. 

Last update: 03 Oct 2014

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