Pfizer Inc. — Xalkori EMA EPAR public assessment report (EMEA/H/C/002489, 2012)
Pfizer Inc. · 2012 · EMA EPAR public assessment report · company profile →
Report summary
Pfizer's XALKORI (crizotinib) received conditional marketing authorization from the CHMP for ALK-positive advanced NSCLC due to unmet medical needs. Efficacy data from studies like A8081001 showed a 60.3% objective response rate and 9.2 months median progression-free survival in previously treated patients. Non-clinical data revealed broad off-target binding, cardiac effects, and drug interactions via CYP3A4/P-gp. Safety concerns include mutagenicity, reproductive toxicity, phototoxicity, and cardiac issues (RR/QTc prolongation). Common adverse events were noted. The conditional approval requires ongoing confirmatory Phase 3 studies, further safety data, and educational materials for healthcare professionals and patients regarding potential risks.
Key findings — cited to the page
| All causality Grade 3-4 AEs | 51.7 % | crizotinib in Study 1001 · p.62 |
| Grade 5 AEs | 11.6 % | crizotinib in Study 1005 · p.62 |
| All causality Grade 3-4 AEs | 34.6 % | crizotinib in Study 1005 · p.62 |
| Grade 5 AEs | 15.4 % | crizotinib in Study 1001 · p.62 |
| most common Grade 3 or 4 adverse reactions (≥ 3%) | increased ALT and neutropenia | Studies 1001 and 1005 · p.72 |
| Grade 3-4 AEs frequency (crizotinib vs chemotherapy) | at least 2-fold greater | Study A8081007 · p.72 |
| Grade 3-4 AEs frequency (chemotherapy vs crizotinib) | 2-fold greater | Study A8081007 · p.72 |
| most common any grade adverse reactions (>20%) | vision disorder, nausea, diarrhoea, vomiting, oedema, constipation, and fatigue | Studies 1001 and 1005 · p.72 |
| median Progression-Free Survival (mPFS) | 10.0 months | crizotinib · p.5 |
| Percentage of lung cancers that are NSCLC | 85% % | · p.7 |
| Marketing Authorisation Application submission date | 28 July 2011 | XALKORI · p.5 |
| Percentage of total cancer deaths (lung cancer) | 18.2% % | Global · p.7 |
Source: Pfizer Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →