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Johnson & Johnson (NYSE:JNJ) disclosed that FDA accepted and granted Priority Review to a BLA for siltuximab (CNTO 328) to treat multicentric Castleman's disease (MCD) in patients who are HIV-negative and human herpes virus 8 (HHV-8)-negative. The PDUFA date is not disclosed. An MAA is also under accelerated assessment by EMA for the indication. The pharma submitted the applications in September. Multicentric Castleman's disease is a rare type of Castleman's disease that affects more than one group of lymph nodes in different anatomical areas. Castleman's disease is a B cell proliferative disorder that is not malignant but is nonetheless fatal because of systemic inflammation.
J&J also presented data at the American Society of Hematology meeting showing that IV siltuximab every three weeks plus best supportive care (BSC) led to a greater durable tumor and symptomatic response rate, the primary endpoint, vs. placebo plus BSC (34% vs. 0%, p=0.0012) in the Phase II MCD2001 trial to treat MCD. Median time to treatment failure was not reached in the siltuximab arm vs. 134 days in the placebo arm. The double-blind, international trial enrolled 79 patients with multicentric Castleman's disease who are HIV-negative and HHV-8-negative. Siltuximab is a chimeric mAb against IL-6.
Johnson & Johnson’s Janssen unit has filed siltuximab in the US and EU for the treatment of patients with the rare blood disorder, multicentric Castleman disease (MCD). The disorder leads to the over-production of lymphocytes and enlargement of lymph nodes. Siltuximab has orphan drug status in the US and Europe, and if approved would be the first drug specifically for the treatment of MCD.
The market application submitted by Janssen is for the use of siltuximab in patients with MCD who do not have HIV or human herpes virus-8. The monoclonal antibody targets and binds to human IL-6, which has been identified as a critical driver in the pathogenesis of MCD.
Jump up^Rossi, J. -F.; Négrier, S.; James, N. D.; Kocak, I.; Hawkins, R.; Davis, H.; Prabhakar, U.; Qin, X.; Mulders, P.; Berns, B. (2010). "A phase I/II study of siltuximab (CNTO 328), an anti-interleukin-6 monoclonal antibody, in metastatic renal cell cancer". British Journal of Cancer103 (8): 1154–1162.doi:10.1038/sj.bjc.6605872. PMC2967052. PMID20808314.edit
Jump up^Karkera, J.; Steiner, H.; Li, W.; Skradski, V.; Moser, P. L.; Riethdorf, S.; Reddy, M.; Puchalski, T.; Safer, K.; Prabhakar, U.; Pantel, K.; Qi, M.; Culig, Z. (2011). "The anti-interleukin-6 antibody siltuximab down-regulates genes implicated in tumorigenesis in prostate cancer patients from a phase I study".The Prostate71 (13): 1455–1465. doi:10.1002/pros.21362. PMID21321981.edit
Jump up^Van Rhee, F.; Fayad, L.; Voorhees, P.; Furman, R.; Lonial, S.; Borghaei, H.; Sokol, L.; Crawford, J.; Cornfeld, M.; Qi, M.; Qin, X.; Herring, J.; Casper, C.; Kurzrock, R. (2010). "Siltuximab, a Novel Anti-Interleukin-6 Monoclonal Antibody, for Castleman's Disease". Journal of Clinical Oncology28 (23): 3701–3708. doi:10.1200/JCO.2009.27.2377. PMID20625121.edit