Cheplapharm — Tarceva EMA EPAR variation assessment report (EMEA/H/C/000618, 2005)

Cheplapharm · 2005 · EMA EPAR variation assessment report

Report summary

This EMA assessment report details a Type II variation for Tarceva (erlotinib), extending its indication for first-line treatment of locally advanced or metastatic NSCLC with activating EGFR mutations. Supported by the EURTAC study and non-clinical data, erlotinib demonstrated significant progression-free survival (PFS) benefits over chemotherapy in this patient population. While overall survival (OS) data were often confounded by crossover, erlotinib consistently showed PFS advantages across various first-line and maintenance settings. Its safety profile, characterized by common adverse events like rash and diarrhea, was acceptable and generally favorable compared to chemotherapy, supporting its approval for this indication.

Key findings — cited to the page

Grade 3 or 4 non-hematologic toxicities	17 patients	CALGB30406 study · p.44
Grade 3 or 4 hematologic toxicities	28 patients	CALGB30406 study · p.44
patients with Grade 3 AEs (placebo)	1	SATURN Study (BO18192) · p.42
patients with Grade 3 AEs (erlotinib)	6	SATURN Study (BO18192) · p.42
Grade 3 diarrhoea	3.7 %	Spanish Lung Cancer Group (SLCG) study · p.43
Grade 3 or 4 hematologic toxicities	1 patient	CALGB30406 study · p.44
patients with grade >= 3 AEs	66.2 %	EURTAC study · p.37
patients with grade >= 3 AEs	41.3 %	EURTAC study · p.37
Treatment-related AEs (all grades)	86.7 %	OPTIMAL Study (ML20981) · p.44
patients with >= Grade 3 AEs	19	TARGET study · p.40
Grade 3 skin toxicity	7.4 %	Spanish Lung Cancer Group (SLCG) study · p.43
Grade 3 or 4 non-hematologic toxicities	39 patients	CALGB30406 study · p.44

Source: Cheplapharm ↗ · 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 →