Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

Shots: Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…

ByRidhi RastogiNovember 3, 2025

NEWS

Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

Shots: Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…

ByRidhi RastogiOctober 28, 2025

NEWS

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Shots: The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible pts Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…

ByRidhi RastogiOctober 21, 2025

VIEWPOINTS

Evaluating SDoH in Lupus Nephritis: Roger Levy from GSK in a Stimulating Conversation with PharmaShots

Shots: GSK presented data at the American College of Rheumatology from a multi-center cohort study highlighting the achievement of complete renal response in patients with active lupus nephritis The study evaluated the attainment of modified complete renal response (mCRR) in patients with systemic lupus erythematosus (SLE) and active lupus nephritis (LN), comparing characteristics between mCRR…

BySaurabh ChaubeyApril 2, 2025

NEWS

Genentech Reports the FDA’s sBLA Acceptance for Gazyva to Treat Lupus Nephritis

Shots: Based on positive results from P-III (REGENCY) study, the US FDA has accepted sBLA of Gazyva in Lupus Nephritis; FDA's approval decision is expected by Oct’25 The P-III (REGENCY) study demonstrated improved CRR with Gazyva + standard therapy vs standard therapy alone, along with improvements in complement levels & reductions in anti-dsDNA, markers…

ByRidhi RastogiMarch 5, 2025

VIEWPOINTS

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

Shots: Volker spoke about the granting of marketing authorization by EC to treat adults with active lupus nephritis.The approval was based on the results of the P-III AURORA study Volker also talked about the collaboration between Aurinia and Otsuka Pharmaceutical for the development and commercialization of LUPKYNIS The interview gives an understanding of how Aurinia…

BySenior EditorDecember 7, 2022

Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Evaluating SDoH in Lupus Nephritis: Roger Levy from GSK in a Stimulating Conversation with PharmaShots

Genentech Reports the FDA’s sBLA Acceptance for Gazyva to Treat Lupus Nephritis

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

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