Venclyxto® (venetoclax) given ‘positive opinion’ by the EMA CHMP for use in the treatment of CLL

On the 13th October 2016, the EMA CHMP gave a positive opinion for granting a conditional marketing authorization for Venclyxto®, venetoclax, submitted by AbbVie Ltd. Venclyxto® is intended for treatment of Chronic Lymphocytic Leukemia (CLL) in adults with the 17p deletion or TP53 mutation, being unsuitable for or having failed B-cell receptor (BCR) pathway inhibiting treatment. Use is also indicated in the absence of these genetic abnormalities in adult CLL patients who have failed both BCR pathway inhibition and chemoimmunotherapy.

This follows the recent FDA approval of Venclexta® (venetoclax) on April 11th 2016. The FDA indicates use in CLL patients who have been treated with at least one prior therapy and have a 17p deletion. The FDA do not indicate Venclexta® use in CLL patients with a mutation in TP53, or in the absence of 17p deletion, whereas the EMA does recommend in cases where 17p is present and TP53 is not mutated, but only when other treatments have failed.

Venclyxto® will be available in Europe in 10mg, 50mg and 100mg tablets.

 EMA CHMP Opinion:

On 13 October 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Venclyxto, intended for the treatment of chronic lymphocytic leukaemia (CLL). Venclyxto was designated as an orphan medicinal product on 6 December 2012. The applicant for this medicinal product is AbbVie Ltd.

Venclyxto will be available as 10-mg, 50-mg and 100-mg film-coated tablets. The active substance of Venclyxto is venetoclax, an antineoplastic agent, which acts by inhibiting BCL-2 (B cell lymphoma-2), an anti-apoptotic protein overexpressed by B-cells in CLL, thus inducing tumour cell apoptosis.

The benefits shown in single arm studies with Venclyxto are its ability to produce responses in patients unsuitable for or refractory to B-cell receptor pathway inhibitors and other anticancer medicines. The most common side effects are neutropenia / neutrophil count decreased, diarrhoea, nausea, anaemia, upper respiratory tract infection, fatigue, hyperphosphataemia, vomiting, and constipation.

The full indication is: “Venclyxto monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor."

It is proposed that Venclyxto be prescribed by physicians experienced in the treatment of CLL and the use of anticancer medicines.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

  1. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) Opinion, Venclyxto, 13th October 2016.
  2. United States Food & Drug Administration, News Release, April 11th 2016. FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality.


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