New indication of TACE gazyva chronic lymphocytic leukemia approved by FDA

Roche's gene tech recently announced that the U.S FDA approved gazyva's application for a supplementary biologics license (SBLA), which allows gazyva to be combined with nitrogen mustard benzoate for the treatment of previously untreated patients with chronic lymphoblastic leukemia (CLL) This SBLA is based on Phase 2 data from a one-to-one cll11 study, which shows that gazyva + NBR significantly improves multiple clinical endpoints compared to rituximab + NBR This approval included complete remission (CR) and minimal residual disease (MRD) data from the phase 2 study In addition, the total survival (OS) data of gazyva + N-mustard and N-mustard were added to the label "Compared with rituximab combined with nitrogen mustard benzoate, gazyva is the first and only drug that can significantly improve the progression free survival of patients with previously untreated chronic lymphocytic leukemia," said horning, chief medical officer and global product development director of Genentech, MD "These new data promote our understanding and treatment of this disease, and this approval provides an important treatment option for patients with this refractory disease." This time, SBLA approved to update the prescription information of gazyva with the following data: compared with rituximab + nitrogen mustard of benzoate, the number of patients who achieved complete remission by gazyva + nitrogen mustard of benzoate was about three times that of the former (the complete remission rate of both was 8.8% and 26.1%, respectively) Compared with rituximab + N-mustard benzoate, gazyva + N-mustard benzoate prolonged the progression free survival of patients with previously untreated CLL by almost one year (median progression free survival was 14.9 and 26.7 months, respectively) Among those who achieved complete remission and abnormal blood cell count with or without recovery, 19% (18 / 94) and 6% (2 / 34) of the patients in the gazyva group and the rituximab group were negative for bone marrow MRD, and 41% and 12% of the patients were negative for peripheral blood MRD, respectively A negative MRD means no trace of cancer remains Data from cll11 study phase 1 showed that mortality was 9% (22 / 238) in patients treated with gazyva + N-mustard, compared with 20% in patients treated with N-mustard alone The mean total survival time has not been obtained Gazyva can cause serious or life-threatening side effects, including hepatitis B reactivation, progressive multifocal leukoencephalopathy (PML), infusion response, tumor lysis syndrome, infection, and low leukocyte count The most common side effects of gazyva were transfusion reaction, low leukocyte count, low platelet count, low RBC count, fever, cough, nausea and diarrhea Gazyva is the first drug approved with FDA's breakthrough treatment drug qualification This drug was approved on November 1, 2013 to be combined with nitrogen mustard benzoate for the previously untreated CLL In July 2014, gazyvaro was approved by the European Union for the same indication in Europe under the trade name of gazyvaro Gazyva has also been used in a wide range of development projects for a variety of cancers, including a number of phase 3 studies tested for non-Hodgkin's lymphoma (NHL) http://www.firstwordpharma.com/node/1253573?tsid=28&region_id=4#axzz3MuriCWQc