hich enrolled 304 patients, with 255 of these treated with Zykadia doses ranging between 50mg and 750mg.
The results of the study demonstrated that approximately 96% of the 255 patients who were treated with Zykadia experienced diarrhoea, nausea, vomiting or abdominal pain. The study also found that drug-induced hepatotoxicity occurred in patients treated with Zykadia.
The Study 1 further found that about 3% of the 255 patients experienced a QTc interval increase over baseline greater than 60msec. Pneumonitis was reported in 4% of 255 patients treated with Zykadia, while sinus bradycardia occurred in 1% of 255 patients treated with Zykadia.
The EC's approval of Zykadia was based on the data obtained from two clinical trials known as ASCEND-1 and ASCEND-2, which were open-label, single-arm, global and multicentre studies. The ASCEND-1 study enrolled 246 ALK+NSCLC patients, whereas the ASCEND-2 study enrolled 140 patients with locally advanced or metastatic ALK+ NSCLC.
The results of the ASCEND-1 demonstrated that the patients who were administered with Zykadia 750mg daily after previous treatment with chemotherapy, followed by an ALK inhibitor, experienced ORR of 56.4%, the median DOR was 8.3 months, and the median PFS was 6.9 months.
The most common adverse reactions found in both of the clinical studies in the patients treated with Zykadia included diarrhoea, nausea, vomiting, tiredness, abdominal pain, decreased appetite, constipation, rash, heartburn and anaemia.
Trade Name：Zykadia
Generic Name：ceritinib
Synonym：LDK378
Chemical Name:5-Chloro-N2-[2-isopropoxy-5-methyl-4-(4-piperidinyl)phenyl]-N4-[2-(isopropylsulfonyl)phenyl]-2,4-pyrimidinediamine
CAS number：1032900-25-6
Mechanism of Action:Anaplastic lymphoma kinase inhibitor
Clinical Trail Data:among 163-treated patients, Zykadia achieved an overall response rate (ORR) of 54.6% and a median duration of response (DOR) of 7.4 months
Dosage and Administration:750 mg orally once daily
Date of Approval: April 29, 2014
Indication：ALK positive non-small cell lung cancer (ALK+ NSCLC)
Company:Novartis Pharmaceuticals Corporation
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fff5d805-4ffd-4e8e-8e63-6f129697563e
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