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Adverse event reporting can be found at the bottom of the page
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Real World Evidence
The information on this website is based on data from adult patients with ALK+ NSCLC treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics for Great Britain. For XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland 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 patients with either ALK+ or ROS1+ advanced NSCLC were hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, neutropenia, and QT interval prolongation. 18% of patients (n=1,722) permently discontinued treatment.1
Adverse events occurring in ≥20% of patients in XALKORI® clinical trials (n=1,772)1†‡
| 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
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PP-UNP-GBR-7812. January 2024