ZYKADIA - CBNPC (céritinib)

Key points

Favourable opinion for maintenance of reimbursement in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

In the case of ALK-positive NSCLC, treatment has been significantly modified by the arrival of anti-ALK targeted therapies, the first of which was crizotinib, which has demonstrated its superiority compared to systemic chemotherapy. Other anti-ALK tyrosine kinase inhibitors (TKIs) have been developed subsequently (ceritinib and alectinib). Given its demonstrated superiority versus crizotinib in terms of progression-free survival and risk of intracranial disease progression, alectinib (ALECENSA) is the option to be favoured in the first-line treatment of ALK+ lung cancer. Depending on the choice of first-line treatment and the type of progression (slow and symptomatic, development of brain metastases, isolated or multiple systemic lesions) of the disease, a switch to another anti-ALK TKI may be considered.

Role of the medicinal product in the care pathway:

ZYKADIA (ceritinib) could be proposed in the event of resistance linked to an ALK-dependent mutation as a possible option after first-line treatment with a TKI (preferentially alectinib) and as second-line treatment if not previously used, in the event of an ALK mutation sensitive to this drug (as determined by resistance phenotyping mechanisms by “liquid biopsy” or in situ sampling).

Considering the evolution of the care pathway, with the integration of second-generation anti-ALK drugs (alectinib, ceritinib, brigatinib, lorlatinib) as first and/or second-line therapy, and the lack of any specific data in patients in whom treatment with these anti-ALKs has failed, the role of ZYKADIA (ceritinib) remains to be specified in this situation.