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DosingSafetyClinical TrialsClinical TrialsXALKORI Clinical TrialsROS1+ NSCLC: PROFILE 1001ALK+ NSCLC: PROFILE 1014

Real World Evidence

Real World EvidenceReal World EvidenceSequential XALKORI® and Ceritinib in ALK+ NSCLCXALKORI® and Post-Progression Treatment in ALK+ NSCLC


The information on this website is based on data from adult patients with ALK (anaplastic lymphoma kinase)-positive / ROS 1-positive advanced NSCLC (non small cell lung cancer) treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics. XALKORI® (crizotinib) Prescribing Information click here. Adverse event reporting information can be found at the bottom of the page.

XALKORI® Safety Profile

The safety of XALKORI® has been evaluated in 1,722 patients with non-small cell lung cancer (NSCLC). This includes 1,669 patients with ALK+ advanced NSCLC from two randomised Phase 3 studies (PROFILE 1007 and PROFILE 1014) and two single-arm studies (PROFILE 1001 and PROFILE 1005), and 53 patients with ROS1+ advanced NSCLC from a single-arm study (PROFILE 1001). All patients received a starting dose of 250 mg XALKORI® taken orally, twice daily, continuously.*1

The most serious adverse reactions in 1,722 patients with either ALK+ or ROS1+ advanced NSCLC were hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, neutropenia, and QT interval prolongation. Adverse events associated with permanent treatment discontinuation occured in 302 (18%) of patients of which the most frequent were ILD (1%) and elevated transaminases (1%)1.

Adverse events occurring in ≥20% of patients in XALKORI® clinical trials (n=1,772)1†

The adverse reactions listed in the table are presented by system organ class Event terms that represent the same medical concept or condition and were grouped together and reported as a single adverse drug reaction:

System organ class Very Common (≥ 1/10 patients)
Blood and lymphatic disorders Neutropenia (22%)                                
Metabolism and nutrition disorders Decreased appetite (30%)
Nervous system disorders Neuropathy (25%)
Dysgeusia (21%)
Eye disorders Vision disorder (63%)
Cardiac disorders Dizziness (26%)
Gastrointestinal disorders Vomiting (51%)
Diarrhoea (54%)
Nausea (57%)
Constipation (43%)
Abdominal pain (21%)
Hepatobiliary disorders Elevated transaminases (32%)
General disorders and administration site conditions          Oedema (47%)
Fatigue (30%)

Adapted from XALKORI® Summary of Product Characteristics.1

*For ALK+ patients in PROFILE 1014, the median duration of study treatment was 47 weeks for the XALKORI® arm (n=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive XALKORI® treatment (n=109). For ALK+ patients in PROFILE 1007, the median duration of study treatment was 48 weeks for the XALKORI® arm (n=172). For ALK+ NSCLC patients in PROFILE 1001 (n=154) and PROFILE 1005 (n=1063), the median duration of treatment was 57 and 45 weeks, respectively. For ROS1-positive NSCLC patients in PROFILE 1001 (n=53), the median duration of treatment was 101 weeks.1† The patients described reflect exposure to XALKORI® in 1,669 patients with ALK+ advanced NSCLC from two randomised Phase 3 studies and two single-arm studies, and in 53 patients with ROS1+ advanced NSCLC from a single-arm study (for a total of 1,722 patients).1ALK: anaplastic lymphoma kinase, ILD: interstitial lung disease, NSCLC: non-small cell lung cancerReferenceXALKORI® Summary of Product Characteristics 
PP-XLK-IRL-0263 February 2024 Legal Category S1A Further information is available on request
Clinical Trials

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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