Product Dossier
ZYKADIA
Product Dossier for ZYKADIA (ceritinib, Novartis Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Novartis Pharmaceuticals
- Active ingredient: ceritinib
- Therapeutic area: Oncology
- Same area: TALZENNA
- Same area: ZARZIO
What it is
Zykadia is a monotherapy for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or who are intolerant of crizotinib.
Approved indications
— ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients whose disease has progressed on or who are intolerant of crizotinib.
Key safety warnings
The documents provided do not contain information about key safety warnings for Zykadia.
PBS listing
Zykadia 150 mg capsules are listed on the PBS as a single item with authority required restriction at an ex-manufacturer price of A$6771.89.
Regulatory history
Zykadia ceritinib 150 mg hard capsule was first registered on the ARTG on 31 March 2016. In November 2016, the PBAC recommended listing for ALK-positive locally advanced or metastatic NSCLC patients with authority required general schedule restriction. In November 2017, the PBAC recommended a change to the PBS listing to allow ceritinib to be used as first-line therapy for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).