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EMA Recommends Granting a Marketing Authorisation for Duvelisib

PI3K inhibitor is intended for the treatment of relapsed or refractory chronic lymphocytic leukaemia and refractory follicular lymphoma
09 Apr 2021
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 25 March 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product duvelisib (Copiktra), intended for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) and refractory follicular lymphoma (FL).

The applicant for this medicinal product is Verastem Europe GmbH.

Copiktra will be available as 15 mg and 25 mg hard capsules. The active substance of Copiktra is duvelisib, an anti-neoplastic agent (ATC code: L01EM04) which acts by inhibiting phosphatidylinositol 3- kinase p110δ (PI3K-δ) and PI3K-γ. These enzymes are involved in the proliferation and survival of malignant B-cell lines and primary CLL cells, and in immunological pathways in the tumour microenvironment of malignant B cells.

The benefits of Copiktra are that it prolongs the survival time without any progression of the disease as compared to ofatumumab in patients with CLL who have received 2 or more prior lines of treatment and induces tumour responses in patients with FL who have received 2 or more prior treatments.

The most common side effects are respiratory tract infections, neutropenia, anaemia, thrombocytopenia, headache, dyspnoea, cough, decreased appetite diarrhoea/colitis, nausea, vomiting, abdominal pain, constipation, rash, musculoskeletal pain, arthralgia, pyrexia, fatigue and increased transaminases.

The full indication is the treatment of adult patents with:

  • Relapsed or refractory CLL after at least two prior therapies.
  • FL that is refractory to at least two prior systemic therapies.

Copiktra should be prescribed by physicians experienced in the treatment of cancer.

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

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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