European Medicines Agency Recommends Granting a Conditional Marketing Authorisation for Ceritinib

It is intended for the treatment of ALK-positive advanced NSCLC previously treated with crizotinib

On 26 February 2015 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product ceritinib (Zykadia), 150 mg, hard capsule, intended for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally-advanced or metastatic non-small cell lung cancer (NSCLC) previously treated with crizotinib.

The applicant for this medicinal product is Novartis Europharm Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Zykadia is ceritinib, a protein kinase inhibitor (L01XE28), inhibiting autophosphorylation of ALK, ALK mediated phosphorylation of downstream signalling proteins and proliferation of ALK dependent cancer cells.

The benefits with ceritinib are its important activity on ALK-positive NSCLC in patients previously treated with crizotinib, with an objective response rate of 56.4% and 37.1% in a phase I and II study, respectively. The median duration of response was 8.3 and 9.2 months, respectively. 

The most common side effects are diarrhoea, nausea, vomiting, fatigue, liver laboratory test abnormalities, abdominal pain, decreased appetite, constipation, rash, blood creatinine increased, oesophageal disorder and anaemia. The most serious adverse reactions are hepatotoxicity, gastrointestinal effects, QT interval prolongation, bradycardia, interstitial lung disease/pneumonitis and hyperglycaemia. 

A pharmacovigilance plan for ceritinib will be implemented as part of the marketing authorisation.

The approved indication is: "Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib". 

It is proposed that ceritinib be prescribed by physicians experienced in the treatment of anti-cancer medicinal products.

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.

The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for ceritinib and therefore recommends the granting of the marketing authorisation. The marketing authorisation is conditional. 

A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.