Seattle Genetics to comply with UN drugs to THE FDA (Reuter)
LOS ANGELES (Reuters)-a pivotal trial of experimental cancer targeting antibody Seattle Genetics for sick and UN Crowfoot Hodgkin the study found that more than a third country realized all point reduction of cancer.
The company also said he hopes to submit the drug, brentuximab vedotin, u. s. regulator in the first half of next year for the sick and night Crowfoot Hodgkin or the UN UN large cell anaplastic (ALCL) who suspended in response to other thérapies. The company was a précédemment soumission would in the first half of 2011.
Was '' our goal should submit in the first season, there is a review accéléré economic and trade market in 2011, "Chief Executive of Clay Siegall Seattle genetics said in an interview by telephone.
Judging by vedotin brentuximab compared with another drug, but rate reduction on all fronts for patients in the same way tends, Pasco Bachelor, he said.
The company developed UN drug and medicine Takeda Co., Japan and European regulators to discuss a possible first half of 2011 soumission.
Seattle Genetics said in September to 75 percent of patients of judging the remissions 102 or UN tumors at least 50 percent. Trial involving patients who were responding to standard traitements lymphatique for breast cancer.
Full results presented at the Sunday at the annual meeting of the American Society of tid blood in Orlando, Florida was a type of tumor reduction in 94 percent of patients.
Brentuximab vedotin link antibody targeting tumors for a chemotherapy drug cancer-killing a goal and to limit impacts on one side. Must be on a house in antigene who expressed in UN Crowfoot Hodgkin, different kinds of T-cell UN and other hematologic malignancies.
Patients in the process responded to drugs to a médian two weeks 29, according to a review independent. Among patients achieve remission, médian durée of response was no longer médian arrived in wake of rising nearly a year.
Seattle Genetics said you serious conditions in the process, neutropenia, you give level of white blood cell (20 percent of patients), which he saw about neuropathie sensory (8 percent), low platelet count (8 percent) and anemia (6 percent).
Siegall estimated that there ready to 8,000 patients in the United States and UN Crowfoot Hodgkin réfractaires incisives you and ALCL.
Full results of a two-stage trial moist vedotin brentuximab in ALCL patients scheduled for presentation at a news conference Hematology on Tuesday. Top-line results, reported that genetics Seattle, Washington in October, showed that 86 percent of patients responded to process drug antibody.
The company also study the drug as an initial treatment for UN Crowfoot Hodgkin and as a maintenance therapy.
Leerink Swann estimated sales of the 2010-2015 period brentuximab vedotin area 302 million.
(Modification not Steve Orlofsky)
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