Sutent (sunitinib malate) has received a European Association of Urology 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.
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 usein 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-targeteddrugs 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 achievesignificantly better progression free survival than was possible with previous standard ofcare therapy, interferon-alpha (IFNα). The 1st line recommendation of sunitinib malate inthe EAU Guidelines is an important step forward in ensuring that this exciting newtreatment 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 forUrological Cancer (AUO) and Head of Department of Urology, Charit? CampusBenjamin Franklin, Berlin.
The EAU guidelines are based upon a comprehensive independent evaluation of clinicaltrial data and other resources relating to the treatment of mRCC, designed to assisturologists in implementing an evidence-based approach in their clinical practices.
“Achieving EAU guideline recognition for Sutent so soon after the EU marketingauthorization for the first line treatment of mRCC demonstrates what an importanttreatment option sunitinib malate has already become for physicians managingmetastatic renal cell carcinoma” said Dr. Robin Wiltshire Medical Director, OncologyEurope.
Clinical Studies
The European Commission’s full marketing authorization for Sutent in January 2007 wasbased 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 ofcare.
Patients taking sunitinib malate had more than doubled prolonged progression-freesurvival (PFS) in first-line treatment for mRCC.
Patients in the sunitinib malate arm experienced 11-month median PFS ? more thandouble the 5-month median PFS observed with IFNα.2
Sunitinib malate demonstrated a 5-fold higher objective response rate (ORR)compared with IFNα in first-line mRCC treatment (31% vs. 6%).2
Sunitinib malate is generally well tolerated with fewer discontinuations than IFNα.Fewer patients discontinued the medicine because of treatment-related adverseevents (8% vs. 13%).2
Sunitinib malate’s side effects in clinical studies for the treatment of mRCC weregenerally mild or moderate. The most common treatment-related adverse events of anygrade 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 malateis indicated for the treatment of unresectable and/or metastatic malignantgastrointestinal stromal tumors (GIST) after failure of imatinib mesylate treatment due toresistance 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 theinitial indications that the European Commission conditionally authorized in July 2006.
Based on results from two phase II studies in cytokine refractory mRCC,3,4 theCommission 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 ofrelevant clinical endpoints such as progression-free survival (PFS). Following evaluationof clinical data submitted by Pfizer, the European Medicines Agency (EMEA)recommended removing the “conditional” status; it also recommended extending theindication to the treatment of advanced and/or metastatic RCC.5 The European
Commission has formally endorsed the recommendations.