Roche’s GAZYVA FDA approval has already rewritten the lupus nephritis playbook — it turned a long-standing oncology B-cell drug into a validated, kidney-saving option. It proved that aggressive B-cell targeting can materially boost complete renal responses when added to standard therapy. The GAZYVA approval (driven by the phase II NOBILITY and phase III REGENCY data) gives clinicians a new, evidence-backed tool to chase remission, pressures payers and guideline panels to rework algorithms, and forces rivals to prove either better efficacy, safer long-term profiles, or meaningful convenience advantages. Can Roche keep the lead? Short answer: Maybe — but the field is no...
