Tarceva

Oncology· 201 cited findings· 1 source document

Company: Cheplapharm

What the regulatory reviews say

Tarceva (erlotinib) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. This indication was an extension approved via a Type II variation (EMEA/H/C/000618/II/0020) on 21 July 2011.

In a Phase III study (ML 20650, EURTAC), erlotinib demonstrated a median progression-free survival (PFS) of 9.7 months, compared to 5.2 months in the chemotherapy arm. This resulted in a PFS gain of 4.5 months for the erlotinib arm. The investigator-assessed PFS Hazard Ratio was 0.42 (95% CI: 0.27-0.64) with a p-value of <0.0001. The event-free rate at 1 year was 37% in the erlotinib arm versus 12% in the chemotherapy arm.

Safety data indicate that 66.2% of patients experienced grade >= 3 adverse events. Serious adverse events (SAEs) occurred in 25.7% of patients, with 2.4% being treatment-related. Treatment-related adverse events of all grades were reported in 86.7% of patients. Deaths occurred in 35-36% of patients, with 7-13% occurring during active treatment.

Key figures — cited to the source page

Median PFS in erlotinib arm (investigator-assessed)	9.7	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.14
Median PFS in chemotherapy arm (investigator-assessed)	5.2	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.14
PFS HR (investigator-assessed)	0.42	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.14
PFS p-value (investigator-assessed)	<0.0001	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.14
patients with grade >= 3 AEs	66.2	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.37
SAEs	25.7	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.38
CHMP Opinion Date	21 July 2011	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.1
Scope of variation	Extension of indication of Tarceva for the first-line treatment of locally advanced or metastatic NSCLC with activating EGFR mutations.	Cheplapharm — Tarceva EMA EPAR variation assessment report, p.2

Source documents

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

Explore the full evidence

All 201 cited findings for Tarceva — searchable, comparable and answerable in plain language — are in the Oncology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.