Siltuximab regulatory update

Johnson & Johnson's Janssen R&D LLC subsidiary submitted a BLA to FDA and an MAA to EMA for siltuximab to treat multicentric Castleman's disease (MCD) in patients who are HIV- and human herpes virus-8 (HHV-8)-negative. J&J said EMA granted accelerated assessment for the MAA. The company also said it requested Priority Review from FDA. The chimeric mAb against IL-6 is in Phase II testing for the indication. Siltuximab also is in Phase II testing for multiple myeloma (MM) and has completed a Phase II trial for metastatic prostate cancer that did not respond to hormone therapy. ...