Afinitor® approved in EU as first treatment proven to benefit
patients with advanced kidney cancer a
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Afinitor more than doubled median time without tumor growth and reduced the risk of disease progression or death by 67% compared with placebo * Patients with advanced kidney cancer have limited options once they experience tumor progression after VEGF-targeted therapy * Several European treatment guidelines recently updated to recommend Afinitor as second-line therapy for advanced kidney cancer * Phase III trials underway to explore potential in multiple additional cancersBasel, August 6, 2009 - The European Commission (EC) has approvedAfinitor® (everolimus) tablets for the treatment of patients withadvanced renal cell carcinoma (RCC) whose disease progressed on orafter treatment with vascular endothelial growth factor(VEGF)-targeted therapy.Nearly 40% of all RCC patients have advanced cancer at time ofdiagnosis, meaning that their tumors have spread outside of thekidneys[1]. Standard initial treatment for these patients may includeVEGF-targeted therapies[2]. Prior to Afinitor, there were no proventreatment options for advanced RCC patients whose cancer progressedwhile on or after treatment with VEGF-targeted therapy."This approval means that across Europe thousands of patients withadvanced kidney cancer now have the opportunity for a clear treatmentpath with Afinitor if their disease progresses after treatment with atargeted therapy," said David Epstein, President and CEO, NovartisOncology, Novartis Molecular Diagnostics.The EC based its approval of Afinitor on data from a pivotal PhaseIII trial demonstrating that Afinitor, when compared with placebo,more than doubled the median time without tumor growth or death inpatients with advanced kidney cancer whose disease progressedfollowing prior VEGF-targeted therapy (4.9 vs. 1.9 months).Additionally, the data showed Afinitor reduced the risk of diseaseprogression or death by 67% based on the primary endpoint ofprogression-free survival (PFS) (hazard ratio=0.33 with 95%confidence interval 0.25 to 0.43; P<0.0001)[3].Several European treatment guidelines have been updated to recommendAfinitor as a second-line advanced kidney cancer therapy afterprogression on targeted therapies, including those from the EuropeanAssociation of Urology (EAU), the Spanish Oncology GenitourinaryGroup (SOGUG), the European Organisation for Research and Treatmentof Cancer (EORTC), the European Society for Medical Oncology (ESMO)and the UK Consensus Guidelines[4],[5],[6],[7],[8].The EC decision applies in all 27 European Union (EU) member states.Afinitor is currently under regulatory review in Switzerland, Japanand other countries.Study detailsThe approval is based on data from RECORD-1 (REnal Cell cancertreatment with Oral RAD001 given Daily), the largest Phase IIIclinical trial to study the effects of an oral mTOR inhibitor inadvanced RCC patients whose cancer progressed despite priorVEGF-targeted treatment[9]. In February 2008, based on arecommendation from an independent data monitoring committee,Novartis stopped the trial after interim results showed that patientsreceiving Afinitor experienced a significant delay in cancerprogression or death compared with patients receiving placebo.This international, multicenter, randomized, double-blind clinicaltrial involved 416 patients with advanced RCC whose cancer progresseddespite prior treatment with sunitinib or sorafenib. Prior therapywith bevacizumab, interferon alfa and interleukin-2 was allowed.Patients were randomized to receive Afinitor (10 mg) daily orplacebo, in conjunction with best supportive care. The primaryendpoint of the study was PFS, which was assessed via a blinded,independent, central radiological review[9].About RCCRenal cell carcinoma, which accounts for approximately 2% of all newcancers, is often referred to as kidney cancer[10]. The occurrencerates of RCC are rising steadily around the world due, in part, tosmoking and obesity[11]. In the EU, there were more than 63,000 newcases of RCC diagnosed and more than 26,000 people died from thedisease in 2006[12].In RCC, cancer cells develop in the lining of the kidney's tubes andgrow into a tumor. If left untreated, the tumor can spread toneighboring lymph nodes and eventually to other organs[13],[14].About AfinitorIn the EU, Afinitor is indicated for patients with advanced RCC whosedisease progressed on or after treatment with VEGF-targeted therapy.Afinitor is also approved in the US to treat advanced RCC afterfailure of treatment with sunitinib or sorafenib.In cancer cells, Afinitor continuously targets mTOR, a protein thatacts as a central regulator of tumor cell division, blood vesselgrowth and cell metabolism. Afinitor is being studied in multiplecancer types, including RCC, neuroendocrine, breast, gastric andhepatocellular carcinoma (HCC), as well as tuberous sclerosis complex(TSC) and non-Hodgkin's lymphoma.The active ingredient in Afinitor is everolimus, which is availablein different dosage strengths under the trade name Certican® for theprevention of organ rejection in heart and kidney transplantrecipients. Certican was first approved in the EU in 2003.For more information on Afinitor, visit www.afinitor.com.Important safety informationAfinitor is contraindicated in patients with hypersensitivity toeverolimus, to other rapamycin derivatives or to any of theexcipients. Potentially serious adverse reactions to Afinitor includenon-infectious pneumonitis and infections, for which patients shouldbe monitored carefully and treated as needed. In addition,non-infectious pneumonitis may require temporary dose reductionand/or interruption or discontinuation. Patients with systemicinvasive fungal infections should not receive Afinitor. Oralulceration is a common side effect of Afinitor. Renal function, bloodglucose and hematological parameters should be evaluated prior to thestart of therapy with Afinitor and periodically thereafter.Co-administration with CYP3A4 or P-glycoprotein inhibitors andinducers should be avoided. If co-administration of a moderate CYP3A4and/or PgP inhibitor or inducer cannot be avoided, dose adjustmentsof Afinitor can be taken into consideration. The use of live vaccinesshould be avoided by patients taking Afinitor. Afinitor should not beused in patients with severe hepatic impairment. Patients withgalactose intolerance, Lapp lactase deficiency or glucose-galactosemalabsorption should not take Afinitor. Caution should be used duringthe peri-surgical period as Afinitor may impair wound healing.Afinitor is not recommended during pregnancy or for women ofchildbearing potential not using contraception. Afinitor may causefetal harm in pregnant women.The most common adverse drug reactions (incidence >=1/10) includestomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea,mucosal inflammation, vomiting, cough, infections, peripheral edema,pneumonitis, epistaxis, dry skin, pruritus, dyspnea and abnormaltaste, as well as decreased hemoglobin, lymphocytes, phosphate,platelets, neutrophils, and increased cholesterol, triglycerides,glucose, creatinine, aspartate aminotransferase and alanineaminotransferase.The most frequent grade 3-4 adverse reactions (incidence >=2%) werelymphocytes decreased, glucose increased, hemoglobin decreased,phosphate decreased, cholesterol increased, infections, stomatitis,fatigue and pneumonitis.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "risk," "potential," "may," "can,""potentially," "should," or similar expressions, or by express orimplied discussions regarding future regulatory filings, marketingapprovals or potential new indications or labeling for Afinitor, orregarding potential future revenues from Afinitor. You should notplace undue reliance on these statements. Such forward-lookingstatements reflect the current views of management regarding futureevents, and involve known and unknown risks, uncertainties and otherfactors that may cause actual results with Afinitor to be materiallydifferent from any future results, performance or achievementsexpressed or implied by such statements. There can be no guaranteethat Afinitor will be approved for sale in any additional markets, orthat Afinitor will be approved for any additional indications orlabeling in any market. Nor can there be any guarantee that Afinitorwill achieve any particular levels of revenue in the future. Inparticular, management's expectations regarding Afinitor could beaffected by, among other things, unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; unexpected regulatory actions ordelays or government regulation generally; the company's ability toobtain or maintain patent or other proprietary intellectual propertyprotection; competition in general; government, industry and generalpublic pricing pressures; the impact that the foregoing factors couldhave on the values attributed to the Novartis Group's assets andliabilities as recorded in the Group's consolidated balance sheet,and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. Shouldone or more of these risks or uncertainties materialize, or shouldunderlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected.Novartis is providing the information in this press release as ofthis date and does not undertake any obligation to update anyforward-looking statements contained in this press release as aresult of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in these areas. In 2008, theGroup's continuing operations achieved net sales of USD 41.5 billionand net income of USD 8.2 billion. Approximately USD 7.2 billion wasinvested in R&D activities throughout the Group. Headquartered inBasel, Switzerland, Novartis Group companies employ approximately99,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.References1.The University of Texas MD Anderson Cancer Center. Kidney Cancer.Available athttp://www.mdanderson.org/patient-and-cancer-information/cancer-information/cancer-types/kidney-cancer/index.html.Accessed June 2009.2. National Comprehensive Cancer Network. "NCCN Clinical PracticeGuidelines in Oncology: Kidney Cancer." Available athttp://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf.Accessed March 2009.3. Afinitor® (everolimus) tablets prescribing information. Basel,Switzerland: Novartis International AG; August 2009.4. Ljungberg, B. et al. Guidelines on Renal Cell Carcinoma. EuropeanAssociation of Eurology. March 2009. Available athttp://www.uroweb.org/fileadmin/tx_eauguidelines/2009/Full/RCC.pdf.Accessed June 2009.5. Bellmunt, J. et al. Recommendations from the Spanish GenitourinaryGroup for the treatment of metastatic renal cell cancer. CancerChemotherapy and Pharmacology. March 2009;63 Suppl 1:S1-13.6. Reijke, T. et al. EORTC-GU expert opinion on metastatic renal cellcancer. European Journal of Cancer. March 2009;45(5):765-73.7. Escudier, B. et al. Renal cell carcinoma: ESMO ClinicalRecommendations for diagnosis, treatment and follow-up. Annals ofOncology 20: Suppl 4:iv81-ivb2, 2009.8. Nathan, P. et al. UK guidelines for the systemic treatment ofrenal cell carcinoma. British Journal of Hospital Medicine. Vol. 70,Iss. 5, May 13, 2009.9. Escudier, B. et al. Phase-3 randomized trial of everolimus(RAD001) vs. placebo in metastatic renal cell carcinoma. Presented atthe European Society for Medical Oncology (ESMO) 33rd Congress onSeptember 16, 2008.10. McLaughlin JK, et al. Epidemiologic aspects of renal cellcarcinoma.Semin Oncol. 2006;33(5):527-533.11. Eisen, et. al. Sorafenib for Older Patients with Renal CellCarcinoma. Journal of the Natational Cancer Institute.2008;100(20):1454-1463.12. Ferlay, J. et al. Estimates of the cancer incidence and mortalityin Europe in 2006. Annals of Oncology.18(3):581-92. March 2007.13. National Cancer Institute. "General Information About Renal CellCancer." Available athttp://www.cancer.gov/cancertopics/pdq/treatment/renalcell/patient.Accessed March 2009.14. American Cancer Society. "How Is Kidney Cancer (Renal CellCarcinoma) Staged?" Available athttp://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_How_is_kidney_cancer_staged_22.asp?rnav=cri.Accessed March 2009. # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Denise BrashearNovartis Global Media Novartis OncologyRelations +1 862 778 7336 (direct)+41 61 324 7999 (direct) denise.brashear(at)novartis.com+41 79 593 4202 (mobile)eric.althoff(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth +41 61 324 North America:Metzler-Arnold 9980Pierre-Michel +41 61 324 1065 Richard Jarvis +1 212 830Bringer 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas +41 61 324 8425 Edwin Valeriano +1 212 830Hungerbuehler 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1332932/315780.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Datum: 06.08.2009 - 07:15 Uhr
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