Overall safety profile was similar between doses except for improvement in GI tolerability.
DOSE OPTIMIZATION STUDY (450-mg DOSE WITH FOOD)
450-mg recommended dose with food improves GI tolerability while providing similar exposure and
comparable efficacy and safety to the 750-MG fasted dose1,2
In patients with and
without brain metastases3
Significantly extended PFS in previously treated patients vs chemotherapy3
Further established in the
GI, gastrointestinal; PFS, progression-free survival.
Data based on 750-MG fasted dose.
References: 1. Data on file. Novartis Pharmaceuticals Corp; 2018.
2. Cho BC, Kim D-W, Bearz A, et al. ASCEND-8: a
randomized phase 1 study of ceritinib, 450 mg or 600 mg, taken with a low-fat meal versus 750 mg in
fasted state in
patients with anaplastic lymphoma kinase (ALK)-rearranged metastatic non-small cell lung cancer
J Thorac Oncol.
3. Zykadia Summary of Product Characteristics.
Novartis Pharmaceuticals Corp; 2017.