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guccioutlet  Brentuximab vedotin, whichSeattle Genetics will market as Adcetris, combines an antibody with achemotherapy drug to treat the rare blood cancer in a novel way. The antibodybinds to the CD30-positive Reed-Sternberg cells that are characteristic of thedisease, while the drug -- monomethyl auristatin -- then attacks the internalstructure of the cells.The Oncologic Drugs Advisory Committee based its 10-0vote on the Hodgkin lymphoma indication on the company's open-label trial in whichthree-quarters of the patients treated with brentuximab vedotinhad at leastsome reduction in tumor burden and more than a third had a complete remission.

The trial involved 102 patients, median age31, who had previously failed an autologous stem cell transplant. Patients hada median of four previous chemotherapy regimens and some had had as many as 13previous regimens.Patients were given 1.8 mg/kg of brentuximab vedotin everythree weeks for up to 16 cycles as a 30‑minute outpatient intravenous infusion.The primary endpoint was the overall objective response rate, which was75%.More than one-third of patients had complete remission, and 40% had partialremission. Overall, 94% patients had at least some tumor reduction.

  guccishoes Later in the day, the advisory committee again voted 10-0 that thedrug should also be approved for relapsed or refractory systemic anaplasticlarge cell lymphoma (ALCL).The company's ALCL trial involved 58 patientsbetween the ages of 18 and 64. They were given 1.8mg/kg of brentuximab vedotinintravenously every 21 days for up to 16 cycles.In that trial, 86% of patientsachieved the primary endpoint -- objective response -- and 57% had a completeremission. The median duration of the complete remission was 13.2 months.Themain adverse event with brentuximab vedotin was peripheral neuropathy. Fatigueand nausea were also common.

There have been no new agents approved forthe treatment of Hodgkin lymphoma since 1977 and there are no standard orapproved therapies for patients who are refractory or relapsed after stem celltransplant.The FDA is not required to follow the advice of its advisorycommittees, but it often does.If Seattle Genetics receives acceleratedapproval, it still has to perform a trial confirming that the drug works and issafe.