The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine

summary of the scientific assessment of the committee for medicinal products for human use

Kyriaki Tzogani, Venke Skibeli, Ingunn Westgaard, Marianne Dalhus, Hege Thoresen, Karsten Bruins Slot, Per Damkier, Kenneth Hofland, Jeanett Borregaard, Jens Ersbøll, Tomas Salmonson, Ronny Pieters, Richard Sylvester, Gerald Mickisch, Jonas Bergh, Francesco Pignatti

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, and VEGFR-3. Based on the positive opinion from the European Medicines Agency (EMA), a marketing authorization valid throughout the European Union (EU) was issued for the treatment of advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. The demonstration of clinical benefit for axitinib was based on a phase III, randomized, open-label, multicenter study of axitinib compared with sorafenib in patients with advanced RCC after failure of a prior systemic first-line regimen containing one or more of the following agents: sunitinib, bevacizumab plus interferon-α, temsirolimus, or cytokines. In the primary analysis, a 2-month increase in median progression-free survival (PFS) was observed for axitinib compared with sorafenib (hazard ratio [HR]: 0.665; 95% confidence interval [CI]: 0.544-0.812; p < .0001). In the subgroup of patients with a prior cytokine-containing regimen, the increase in median PFS associated with axitinib was 5.4 months (updated analysis, HR: 0.519; 95% CI: 0.375-0.720; p < .0001). In the subgroup of patients with prior sunitinib treatment, the increase in median PFS was 1.4 months (updated analysis, HR: 0.736; 95% CI: 0.578-0.937; p = .0063). The analysis of overall survival showed no statistically significant survival benefit of axitinib over sorafenib in patients previously treated with cytokine-containing regimens (HR: 0.813; 95% CI: 0.556-1.191) or sunitinib (HR: 0.997; 95% CI: 0.782-1.270). The most common treatment-related adverse events associated with axitinib included diarrhea, hypertension, fatigue, nausea, decreased appetite, dysphonia, and palmar-plantar erythrodysesthesia. Most of these events were mild or moderate in severity. This paper summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu).

OriginalsprogEngelsk
TidsskriftOncologist
Vol/bind20
Udgave nummer2
Sider (fra-til)196-201
ISSN1083-7159
DOI
StatusUdgivet - feb. 2015
Udgivet eksterntJa

Fingeraftryk

Treatment Failure
Confidence Intervals
Disease-Free Survival
European Union
Vascular Endothelial Growth Factor Receptor-1
Dysphonia
Vascular Endothelial Growth Factor Receptor-2
Survival Analysis
axitinib
sunitinib
Marketing
Multicenter Studies
sorafenib

Citer dette

Tzogani, Kyriaki ; Skibeli, Venke ; Westgaard, Ingunn ; Dalhus, Marianne ; Thoresen, Hege ; Slot, Karsten Bruins ; Damkier, Per ; Hofland, Kenneth ; Borregaard, Jeanett ; Ersbøll, Jens ; Salmonson, Tomas ; Pieters, Ronny ; Sylvester, Richard ; Mickisch, Gerald ; Bergh, Jonas ; Pignatti, Francesco. / The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine : summary of the scientific assessment of the committee for medicinal products for human use. I: Oncologist. 2015 ; Bind 20, Nr. 2. s. 196-201.
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title = "The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human use",
abstract = "Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, and VEGFR-3. Based on the positive opinion from the European Medicines Agency (EMA), a marketing authorization valid throughout the European Union (EU) was issued for the treatment of advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. The demonstration of clinical benefit for axitinib was based on a phase III, randomized, open-label, multicenter study of axitinib compared with sorafenib in patients with advanced RCC after failure of a prior systemic first-line regimen containing one or more of the following agents: sunitinib, bevacizumab plus interferon-α, temsirolimus, or cytokines. In the primary analysis, a 2-month increase in median progression-free survival (PFS) was observed for axitinib compared with sorafenib (hazard ratio [HR]: 0.665; 95{\%} confidence interval [CI]: 0.544-0.812; p < .0001). In the subgroup of patients with a prior cytokine-containing regimen, the increase in median PFS associated with axitinib was 5.4 months (updated analysis, HR: 0.519; 95{\%} CI: 0.375-0.720; p < .0001). In the subgroup of patients with prior sunitinib treatment, the increase in median PFS was 1.4 months (updated analysis, HR: 0.736; 95{\%} CI: 0.578-0.937; p = .0063). The analysis of overall survival showed no statistically significant survival benefit of axitinib over sorafenib in patients previously treated with cytokine-containing regimens (HR: 0.813; 95{\%} CI: 0.556-1.191) or sunitinib (HR: 0.997; 95{\%} CI: 0.782-1.270). The most common treatment-related adverse events associated with axitinib included diarrhea, hypertension, fatigue, nausea, decreased appetite, dysphonia, and palmar-plantar erythrodysesthesia. Most of these events were mild or moderate in severity. This paper summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu).",
author = "Kyriaki Tzogani and Venke Skibeli and Ingunn Westgaard and Marianne Dalhus and Hege Thoresen and Slot, {Karsten Bruins} and Per Damkier and Kenneth Hofland and Jeanett Borregaard and Jens Ersb{\o}ll and Tomas Salmonson and Ronny Pieters and Richard Sylvester and Gerald Mickisch and Jonas Bergh and Francesco Pignatti",
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Tzogani, K, Skibeli, V, Westgaard, I, Dalhus, M, Thoresen, H, Slot, KB, Damkier, P, Hofland, K, Borregaard, J, Ersbøll, J, Salmonson, T, Pieters, R, Sylvester, R, Mickisch, G, Bergh, J & Pignatti, F 2015, 'The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human use', Oncologist, bind 20, nr. 2, s. 196-201. https://doi.org/10.1634/theoncologist.2014-0177

The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine : summary of the scientific assessment of the committee for medicinal products for human use. / Tzogani, Kyriaki; Skibeli, Venke; Westgaard, Ingunn; Dalhus, Marianne; Thoresen, Hege; Slot, Karsten Bruins; Damkier, Per; Hofland, Kenneth; Borregaard, Jeanett; Ersbøll, Jens; Salmonson, Tomas; Pieters, Ronny; Sylvester, Richard; Mickisch, Gerald; Bergh, Jonas; Pignatti, Francesco.

I: Oncologist, Bind 20, Nr. 2, 02.2015, s. 196-201.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine

T2 - summary of the scientific assessment of the committee for medicinal products for human use

AU - Tzogani, Kyriaki

AU - Skibeli, Venke

AU - Westgaard, Ingunn

AU - Dalhus, Marianne

AU - Thoresen, Hege

AU - Slot, Karsten Bruins

AU - Damkier, Per

AU - Hofland, Kenneth

AU - Borregaard, Jeanett

AU - Ersbøll, Jens

AU - Salmonson, Tomas

AU - Pieters, Ronny

AU - Sylvester, Richard

AU - Mickisch, Gerald

AU - Bergh, Jonas

AU - Pignatti, Francesco

N1 - ©AlphaMed Press.

PY - 2015/2

Y1 - 2015/2

N2 - Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, and VEGFR-3. Based on the positive opinion from the European Medicines Agency (EMA), a marketing authorization valid throughout the European Union (EU) was issued for the treatment of advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. The demonstration of clinical benefit for axitinib was based on a phase III, randomized, open-label, multicenter study of axitinib compared with sorafenib in patients with advanced RCC after failure of a prior systemic first-line regimen containing one or more of the following agents: sunitinib, bevacizumab plus interferon-α, temsirolimus, or cytokines. In the primary analysis, a 2-month increase in median progression-free survival (PFS) was observed for axitinib compared with sorafenib (hazard ratio [HR]: 0.665; 95% confidence interval [CI]: 0.544-0.812; p < .0001). In the subgroup of patients with a prior cytokine-containing regimen, the increase in median PFS associated with axitinib was 5.4 months (updated analysis, HR: 0.519; 95% CI: 0.375-0.720; p < .0001). In the subgroup of patients with prior sunitinib treatment, the increase in median PFS was 1.4 months (updated analysis, HR: 0.736; 95% CI: 0.578-0.937; p = .0063). The analysis of overall survival showed no statistically significant survival benefit of axitinib over sorafenib in patients previously treated with cytokine-containing regimens (HR: 0.813; 95% CI: 0.556-1.191) or sunitinib (HR: 0.997; 95% CI: 0.782-1.270). The most common treatment-related adverse events associated with axitinib included diarrhea, hypertension, fatigue, nausea, decreased appetite, dysphonia, and palmar-plantar erythrodysesthesia. Most of these events were mild or moderate in severity. This paper summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu).

AB - Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, and VEGFR-3. Based on the positive opinion from the European Medicines Agency (EMA), a marketing authorization valid throughout the European Union (EU) was issued for the treatment of advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. The demonstration of clinical benefit for axitinib was based on a phase III, randomized, open-label, multicenter study of axitinib compared with sorafenib in patients with advanced RCC after failure of a prior systemic first-line regimen containing one or more of the following agents: sunitinib, bevacizumab plus interferon-α, temsirolimus, or cytokines. In the primary analysis, a 2-month increase in median progression-free survival (PFS) was observed for axitinib compared with sorafenib (hazard ratio [HR]: 0.665; 95% confidence interval [CI]: 0.544-0.812; p < .0001). In the subgroup of patients with a prior cytokine-containing regimen, the increase in median PFS associated with axitinib was 5.4 months (updated analysis, HR: 0.519; 95% CI: 0.375-0.720; p < .0001). In the subgroup of patients with prior sunitinib treatment, the increase in median PFS was 1.4 months (updated analysis, HR: 0.736; 95% CI: 0.578-0.937; p = .0063). The analysis of overall survival showed no statistically significant survival benefit of axitinib over sorafenib in patients previously treated with cytokine-containing regimens (HR: 0.813; 95% CI: 0.556-1.191) or sunitinib (HR: 0.997; 95% CI: 0.782-1.270). The most common treatment-related adverse events associated with axitinib included diarrhea, hypertension, fatigue, nausea, decreased appetite, dysphonia, and palmar-plantar erythrodysesthesia. Most of these events were mild or moderate in severity. This paper summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu).

U2 - 10.1634/theoncologist.2014-0177

DO - 10.1634/theoncologist.2014-0177

M3 - Journal article

VL - 20

SP - 196

EP - 201

JO - Oncologist

JF - Oncologist

SN - 1083-7159

IS - 2

ER -