Zykadia® 150 mg hard capsules
Each hard capsule contains 150 mg ceritinib.
For the full list of excipients, see section 6.1.
Hard capsule.
Capsule with white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder.
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.
Treatment with Zykadia should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products.
ALK testing
An accurate and validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
ALK-positive NSCLC status should be established prior to initiation of Zykadia therapy. Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the spe
