Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

FDA Approves Cabazitaxel for Metastatic Hormone-Refractory Prostate Cancer NEW YORK -- June 17, 2010 -- The US Food and Drug Administration (FDA) has approved cabazitaxel (Jevtana) injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen. The approval is based on results from the phase 3 Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere-Containing Regimen (TROPIC) study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen. There was a significant 30% reduction in risk of death from mHRPC among patients taking cabazitaxel with prednisone compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone (P < .0001). Investigator-assessed tumour response rates using Response Evaluation Criteria in Solid Tumors (RECIST) criteria were 14.4% and 4.4% for cabazitaxel-treated and mitoxantrone-treated patients, respectively (P = .0005). No complete responses were observed on either arm. The most common (>= 10%) adverse reactions (grade 1-4) were neutropenia, anaemia, leukopenia, thrombocytopenia, diarrhoea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnoea, dysguesia, cough, arthralgia, and alopecia. The most common (>=5%) grade 3/4 adverse reactions in patients who received cabazitaxel were neutropenia, leukopenia, anaemia, febrile neutropenia, diarrhoea, fatigue, and asthenia. The most common adverse reactions leading to treatment discontinuation in the cabazitaxel group were neutropenia and renal failure. Treatment discontinuations due to adverse drug reactions occurred in 18% of patients who received cabazitaxel and in 8% of patients who received mitoxantrone. Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 cabazitaxel-treated patients (5%) and in 3 mitoxantrone-treated patients (<1%). The most common fatal adverse reactions in the cabazitaxel arm were infections (n = 5) and renal failure (n = 4). One death was due to diarrhoea-induced dehydration and electrolyte imbalance. SOURCE: sanofi-aventis E-mail this page to a friend or colleague! To print, use this version