Berlin, March 22 – Sutent® (sunitinib malate) has received a European Association of Urology (EAU) recommendation, as first-line therapy in patients with metastatic renal cell carcinoma of good and intermediate risk, just two months after gaining EU marketing authorization for first line use in all patients with advanced and/or metastatic renal cell carcinoma (mRCC).1 These new EAU guidelines, issued today in Berlin, put Sutent®, the first multi-targeted tyrosine kinase inhibitor to be approved in the EU for first-line use in mRCC, at the forefront of drug therapy for this devastating condition.
Sunitinib malate is an oral therapy belonging to a new class of dual-action multi-targeted drugs that attack cancer by inhibiting tumor growth and starving the tumor of blood, thereby reducing its ability to continue to divide and grow.
"There is strong clinical evidence to support the use of sunitinib malate to achieve significantly better progression free survival than was possible with previous standard of care therapy, interferon-alpha (IFNα). The 1st line recommendation of sunitinib malate in the EAU Guidelines is an important step forward in ensuring that this exciting new treatment option becomes a new standard of care in mRCC therapy across Europe", said Prof. Kurt Miller, member of the executive board of the German Working Group for Urological Cancer (AUO) and Head of Department of Urology, Charité Campus Benjamin Franklin, Berlin.
The EAU guidelines are based upon a comprehensive independent evaluation of clinical trial data and other resources relating to the treatment of mRCC, designed to assist urologists in implementing an evidence-based approach in their clinical practices.
"Achieving EAU guideline recognition for Sutent so soon after the EU marketing authorization for the first line treatment of mRCC demonstrates what an important treatment option sunitinib malate has already become for physicians managing metastatic renal cell carcinoma" said Dr. Robin Wiltshire Medical Director, Oncology Europe.
Clinical Studies
The European Commission's full marketing authorization for Sutent in January 2007 was based on data from a large phase III mRCC trial2. In this multicenter international study, 750 patients received sunitinib malate or interferon-alfa (IFNα), the current standard of care.
Patients taking sunitinib malate had more than doubled prolonged progression-free survival (PFS) in first-line treatment for mRCC.
Sunitinib malate's side effects in clinical studies for the treatment of mRCC were generally mild or moderate. The most common treatment-related adverse events of any grade were fatigue, gastrointestinal disorders such as diarrhea, nausea, stomatitis, dyspepsia, and vomiting; skin discoloration; dysgeusia; hypertension; and anorexia.2
The proportion of patients with treatment-related severe adverse events (grade 3 and 4) was relatively low in both groups (sunitinib malate vs. IFNα).2
In addition to its full authorization for the treatment of mRCC in the EU, sunitinib malate is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.
Background on Sunitinib malate's full marketing authorization for mRCC
Full approval of sunitinib malate for the treatment of mRCC includes a broadening of the initial indications that the European Commission conditionally authorized in July 2006.
Based on results from two phase II studies in cytokine refractory mRCC,3,4 the Commission had granted Pfizer conditional marketing authorization in the EU.
The condition was that Pfizer would provide further data on the drug's effect in terms of relevant clinical endpoints such as progression-free survival (PFS). Following evaluation of clinical data submitted by Pfizer, the European Medicines Agency (EMEA) recommended removing the "conditional" status; it also recommended extending the indication to the treatment of advanced and/or metastatic RCC.5 The European
Commission has formally endorsed the recommendations.
For further information please contact:
Reynolds-MacKenzie
Eva Reynolds / Alison MacKenzie
Tel: 00 44 (0) 20 7031 4360 / 4361
Mobile: 07989 353 779 / 07890 265 454
Email: alison@reynoldsmackenzie.com / eva@reynoldsmackenzie.com
Notes to the editors
For more information, please visit www.pfizer.com .
References
European Urology