Subcutaneous rituximab regulatory update

FDA’s Oncologic Drugs Advisory Committee voted 11-0 that the benefit-risk of subcutaneous rituximab from Roche’s Genentech unit is favorable. The product is under review for previously untreated follicular lymphoma, previously untreated diffuse large B cell lymphoma (DLBCL), relapsed or refractory low-grade or follicular lymphoma and previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL). The PDUFA date is June 26. The subcutaneous formulation of rituximab, a chimeric mAb against CD20 antigen, uses Halozyme’s Enhanze recombinant human hyaluronidase (rHuPH20) drug delivery technology. It is approved in the EU for CLL, DLBCL and non-Hodgkin’s lymphoma (NHL)...