Afinitor
Oncology· 287 cited findings· 2 source documents
Company: Novartis AG →
What the regulatory reviews say
Afinitor (everolimus) is indicated for the treatment of advanced renal cell carcinoma. In a Phase III trial with 416 enrolled patients (277 in the everolimus arm and 139 in the placebo arm), the median Progression-Free Survival (PFS) for Afinitor was 4.90 months, compared to 1.87 months for placebo. The PFS Hazard Ratio was 0.33 (95% CI: 0.25-0.43). Median Overall Survival (OS) was 14.75 months for Afinitor and 14.39 months for placebo, with an OS Hazard Ratio of 0.87 (95% CI: 0.65-1.1).
Notable safety findings include a 39% incidence of Grade 3 or 4 adverse reactions with Afinitor, compared to 7% for placebo. Discontinuation due to adverse events occurred in 10.4% of Afinitor patients versus 3.7% in the placebo group. Non-infectious pneumonitis was observed in 12% of patients. Adverse reactions resulting in permanent discontinuation were 7% for Afinitor and 0% for placebo.
Afinitor received a positive opinion for Marketing Authorisation from the CHMP on 29 May 2009 and Marketing Authorisation in the USA on 30 March 2009. It was designated an orphan medicinal product on 5 June 2007.
Key figures — cited to the source page
| Median PFS (Afinitor) | 4.90 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.73 |
| Median PFS (placebo) | 1.87 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.73 |
| PFS HR | 0.33 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.72 |
| Median OS (Afinitor) | 14.75 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.73 |
| Median OS (placebo) | 14.39 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.73 |
| Grade 3 or 4 adverse reactions (Afinitor) | 39 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.73 |
| Grade 3 or 4 adverse reactions (placebo) | 7 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.73 |
| Marketing Authorisation date in USA | 30 March 2009 | Novartis AG — Afinitor EMA EPAR public assessment report (EM, p.3 |
Source documents
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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.