A new therapy for lung cancer may experience a rush to the market after a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The CHMP recommends granting a conditional marketing authorisation for ceritinib, a recently developed lung cancer therapy.

Ceritinib is 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.

Ceritinib is a protein kinase inhibitor that inhibits 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.

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.

Source: European Medicines Agency