Tags : Gazyva


Roche’s Gazyva (obinutuzumab) Receives FDA’s Breakthrough Therapy Designation for Lupus

Shots: The FDA’s BT designation is based on P-II NOBILITY (NCT02550652) study assessing Gazyva in combination with mycophenolate mofetil/mycophenolic acid and corticosteroids vs PBO + MMF/MPO and corticosteroids in 126 patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis The P-II NOBILITY study resulted in meetings its 1EPs & 2EPs i.e, complete renal […]Read More


AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First

Shots: The combinational approval is based P-III iLLUMANTE (PCYC-1130) study results assessing Imbruvica + Gazyva vs chlorambucil + Gazyva in patients with 1L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) aged ≥ 65 years The P-III iLLUMANTE study resulted in 77% reduction in risk of progression or death and has also shown 85% reduction in progression […]Read More