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Real World Evidence
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.
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
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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PP-UNP-IRL-0784. June 2024