FDA Grants Ibrutinib/Rituximab Priority Review for Waldenstrom Macroglobulinemia

June 25, 2018 – The FDA has granted a priority review to a supplemental new drug application (sNDA) ibrutinib for use in combination with rituximab as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia, according Pharmacyclics (AbbVie) and Janssen Biotech, the codevelopers of ibrutinib. The sNDA is based on findings from the phase III iNNOVATE (PCYC-1127) trial presented at the 2018 ASCO Annual Meeting and … (leggi tutto)