FDA grants Johnson & Johnson imbruvica SNDA priority review qualification

Source: Biovalley, June 10, 2014, JNJ and pharmacyclics announced on June 9 that FDA has been reviewed and granted the priority of SNDA for the treatment of chronic lymphoblastic leukemia (CLL) and small Lymphoid Lymphoma (SLL) with the anticancer drug imbruvica (ibrutinib) FDA has designated the target date for the prescription drug user fee Act (PDUFA) of imbruvica SNDA as October 7, 2014 The submission of imbruvica SNDA is based on the data of phase III relocate (pcyc-1112-ca) study The study was a randomized, multicenter, open label, head-to-head study in 391 patients with chronic lymphoblastic leukemia (CLL) and small lymphoid tumor (SLL) who had previously received at least one treatment and were not suitable for purine analog treatment or retreatment The comparison between imbruvica and ofatumumab was made In the study, 195 patients were treated with imbruvica (420mg, once a day) until the disease worsened or unacceptable toxicity, 196 patients were treated with ofatumumab (initial dose of 300mg, followed by 11 times of 2000mg) for 24 weeks In January 2014, according to the recommendation of the independent data monitoring committee (IDMC), the reconate study was terminated in advance IDMC conducted an established mid-term analysis of the resonate study and found significant differences in progression free survival (PFS) between the imbruvica group and the ofatumab group In addition, IDMC suggested that all patients in the ofatumab treatment group should be provided with imbruvica treatment About imbruvica: imbruvica (ibrutinib) is one of the first inhibitors of oral Burton tyrosine kinase (Btk) Btk is a key signal molecule in B cell receptor signal complex, which plays an important role in the survival and proliferation of malignant B cells Imbruvica can block the signal pathway of uncontrolled proliferation and diffusion of malignant B cells In December 2013 and February 2014, FDA approved imbruvica for the treatment of patients with treated mantle cell lymphoma (MCL) and chronic lymphoblastic leukemia (CLL) Johnson & Johnson's Janssen biotechnology and pharmacyclics signed a license agreement in December 2011 to jointly develop and commercialize imbruvica About Arzerra (ofatummab): Arzerra (ofatummab) is an experimental drug of GlaxoSmithKline (GSK) It is an innovative all human monoclonal antibody targeting an antigen epitope of CD20 on the surface of B cell The epitope contains the extracellular macroloop and small loop structure of CD20 Arzerra was approved by FDA and EMA in 2009 and 2010, respectively, for the treatment of unresponsive chronic lymphocytic leukemia (CLL) patients with standard drugs [alemtuzumab, campath or fludarabine] Arzerra has been approved by FDA in April 2014 It is combined with chlorambucil for the first-line treatment of chronic lymphocytic leukemia (CLL) patients with initial treatment and discomfort and fludarabine chemotherapy Arzerra was jointly developed by GSK and genmab.