Regulators have backed Janssen's first-in-class, anti-interleukin-6 (IL-6) Sylvant (siltuximab) for multicentric Castleman's disease, a rare B-cell lymphoproliferative disorder. Sylvant, a chimeric IL-6–neutralizing monoclonal antibody, is the first drug approved in the US and EU to treat this rare disease, although Roche's first-in-class anti-IL-6 receptor (IL-6R) Actemra (tocilizumab) similarly targeted Castleman's. Actemra achieved blockbuster status last year, driven by its sales in rheumatoid arthritis, but it was first approved to treat Castleman's disease in Japan in 2005. Janssen, a Beerse, Belgium–based subsidiary of Johnson & Johnson (J&J), is now developing its antibody for smoldering multiple myeloma, an early stage of the blood cancer. “Our ongoing phase 2 trial is important not just from the drug development point of view, but also in terms of studying the hypothesis that IL-6 is an important driver of the development of multiple myeloma,” says Helgi van de Velde, senior director of oncology R&D at Janssen. Basel-based Roche's Actemra was also studied in multiple myeloma, with little success. “But I'm not sure that you can extrapolate from these results,” says van de Velde, because Sylvant targets the IL-6 ligand rather than its receptor. Most firms have focused their IL-6 and IL-6R efforts on autoimmune and inflammatory indications. AbbVie's ALX-0061, Bristol-Myers Squibb's clazakizumab, J&J's sirukumab, Regeneron's sarilumab, Pfizer's PF-04236921 and other related candidates are in clinical trials for rheumatoid arthritis, psoriatic arthritis, Crohn's disease and lupus.
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