FDA Grants Priority Review to Ibrutinib Plus Obinutuzumab in Frontline CLL

October 17, 2018 – The FDA has granted a priority designation to a supplemental new drug application (sNDA) for ibrutinib for use in combination with obinutuzumab for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The sNDA is based on data from the phase III iLLUMINATE (PCYC-1130) trial, which showed that frontline treatment with ibrutinib combined with obinutuzumab significantly improved … (leggi tutto)