Inlyta axitinib

Oncology· 265 cited findings· 1 source document

What the regulatory reviews say

Inlyta (axitinib) is a drug for which a Marketing Authorisation application was submitted on 19 April 2011, following an Orphan medicinal product designation on 23 February 2011. A Marketing Authorisation in the USA was granted on 27 January 2012, and a CHMP positive opinion was issued on 24 May 2012.

In clinical trials, axitinib demonstrated a median progression-free survival (PFS) of 6.8 months, with a PFS Hazard Ratio of 0.670 (axitinib vs sorafenib) and a p-value of <0.0001. In patients who had previously received a sunitinib-containing regimen, the objective response rate (ORR) for axitinib was 12.9%, compared to 8.7% for sorafenib, with an ORR Risk Ratio of 1.48. For patients who had previously received a cytokine-containing regimen, the ORR for axitinib was 35.7% versus 16.8% for sorafenib, with an ORR Risk Ratio of 2.127 and a p-value of 0.0003. The median duration of response for axitinib was 11 months.

Safety findings included haemorrhages in 22.9% of patients, with Grade 3/4 haemorrhages occurring in 1.9% of patients. In single-agent studies, 26.0% of patients experienced haemorrhages. The incidence of treatment-related grade >3 adverse events in Asian patients was 59.7%.

Key figures — cited to the source page

PFS Hazard Ratio (axitinib vs sorafenib)	0.670	EMA EPAR, p.52
PFS p-value (axitinib vs sorafenib)	<0.0001	EMA EPAR, p.52
Objective response rate in prior cytokine-containing regimen (axitinib)	35.7	EMA EPAR, p.58
Objective response rate in prior cytokine-containing regimen (sorafenib)	16.8	EMA EPAR, p.58
ORR Risk Ratio in prior cytokine-containing regimen (axitinib vs sorafenib)	2.127	EMA EPAR, p.58
Patients experiencing haemorrhages	22.9	EMA EPAR, p.72
Marketing Authorisation in USA date	27 January 2012	EMA EPAR, p.10
CHMP positive opinion date	24 May 2012	EMA EPAR, p.11

Source documents

Pfizer Inc. — Inlyta EMA EPAR public assessment report (EMEA/H/C/002406, 2012) (2012)

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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.