Erlotinib
Oncology· 556 cited findings· 2 source documents
Company: Cheplapharm
What the regulatory reviews say
Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. For patients with tumors without EGFR activating mutations, Erlotinib is indicated when other treatment options are not considered suitable. The drug received its first approval in the EU on 19 September 2005.
In the BR.21 study, a 2:1 randomized, double-blind, placebo-controlled Phase 3 trial, Erlotinib demonstrated a statistically significant improvement in Overall Survival (OS) compared to placebo in the full analysis set (HR 0.76, 95% CI 0.64-0.91; p=0.0018). For the EGFR wild-type subgroup in BR.21, the OS Hazard Ratio for erlotinib versus placebo was 0.75 (95% CI 0.52-1.10; p=0.1443). The difference in Response Rate for EGFR wild-type patients was 3.80.
Safety findings from the BR.21 study indicated that the overall incidence of adverse events (AEs) for erlotinib was 99%. Notable AEs included rash, with an incidence of 75% (Grade 1 or 2 rash: 66%), and diarrhoea, with an incidence of 54% (Grade 1 or 2 diarrhoea: 48%).
Key figures — cited to the source page
| Overall Survival p-value (ITT) | 0.0018 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.14 |
| OS HR for erlotinib vs placebo in full analysis set (BR.21) | 0.76 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.13 |
| OS HR 95% CI lower bound for erlotinib vs placebo in full analysis set (BR.21) | 0.64 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.13 |
| OS HR 95% CI upper bound for erlotinib vs placebo in full analysis set (BR.21) | 0.91 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.13 |
| overall incidence of AEs | 99 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.55 |
| rash incidence | 75 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.55 |
| diarrhoea incidence | 54 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.55 |
| EMA approval date | 19 September 2005 | Cheplapharm — Tarceva EMA EPAR variation assessment report, p.5 |
Source documents
Explore the full evidence
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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.