FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia

July 3, 2018 – The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib in combination with rituximab as a new treatment option for Waldenström’s macroglobulinemia. If approved, the sNDA would expand the prescribing information of ibrutinib in Waldenström’s macroglobulinemia beyond its current approved use as a single agent for all lines of therapy to include combination use with rituximab … (leggi tutto)