With the lupus treatment landscape poised for a shake-up, Roche is hitting the scene in the U.S. with a new green light for its long-approved blood cancer medicine Gazyva.
Early Monday, Roche’s Genentech announced that the FDA cleared Gazyva (obinutuzumab) to treat adults with active lupus nephritis who are taking standard therapy.
The drug will be given as four initial infusions during the first year of treatment, after which it can be administered twice yearly.
Lupus nephritis is a potentially fatal manifestation of the most common form of lupus, systemic lupus erythematosus (SLE), which results in the irreversible loss of filtering structures in the kidneys called nephrons. Many patients with lupus nephritis lose kidney function over time, and, even with the most current treatments, up to one-third of people living with the autoimmune disease progress to end-stage kidney disease, according to Roche.
Enter Gazyva, a monoclonal antibody drug targeting CD20—a protein found on certain types of B cells—which Roche has surmised could move beyond its blood cancer roots to protect the kidneys of those with lupus nephritis from further damage and slow or prevent kidney disease progression to the severest stage. Lupus nephritis is itself a B cell-driven disease.
The FDA signed off on Roche’s thesis as it was borne out in the drugmaker’s late-stage Regency study and phase 2 Nobility trial. In Regency, more than 46% of patients who received Gazyva together with standard therapy hit complete renal response, compared to 33.1% of patients on standard care alone.
“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a statement.
Roche’s med also led to clinically meaningful improvements across complement levels and reductions in anti-double-stranded DNA (anti-dsDNA) antibodies, corticosteroid use and high levels of protein in the urine, which the company spotlighted as signals of improved disease control.
“The approval of Gazyva by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control,” Garraway continued in Roche’s release.
Despite wins on renal response and disease activity metrics, Roche’s drug came up short on secondary responses that tracked patients’ mean change in estimated glomerular filtration rates (eFGR), death or renal-related events and overall renal responses. EGFR is a measure of how well the kidneys are filtering waste and extra water from the blood to make urine.
The move into lupus nephritis comes late into the life span of Gazyva, which was initially endorsed by the FDA in chronic lymphocytic leukemia (CLL) back in 2013. The lupus nephritis nod marks the drug’s fifth, following several green lights in additional CLL and follicular lymphoma indications over the years.
More than 1.7 million people around the world live with lupus nephritis, Roche said in its release. The condition disproportionately affects women and, among women, even more so women of color and those who are of childbearing age. Patients with lupus nephritis who progress to end-stage kidney disease often require dialysis or transplantation to address their disease.
As it stands, the lupus treatment market—across several distinct indications—is dominated by GSK’s biologic Benlysta. The drug, which falls into the B-lymphocyte stimulator (BlyS)-specific inhibitor class—originally passed muster with the FDA in 2011.
More recently, AstraZeneca in 2021 scored an FDA nod for its drug Saphnelo to treat moderate to severe SLE.
Doctors have also used another Roche drug, Rituxan, off-label to treat lupus nephritis for some time now. Roche had previously tried to secure a lupus nod for the CD20 antibody but failed after Rituxan fell short in a phase 3 trial.
Meanwhile, Gazyva has continued to grow sales through its oncology footholds in recent years, delivering 16% growth to 910 million Swiss francs (around $1.15 billion) for all of 2024, according to Roche’s latest annual report (PDF). With the lupus nephritis nod, Gazyva could now reach sales of $1.7 billion by 2030, analysts at GlobalData have predicted.
The FDA endorsement comes less than a week after the European Medicine Agency's Committee for Medicinal Products for Human Use issued a similar recommendation for Gazyva, in tandem with mycophenolate mofetil, to treat lupus nephritis. The drug will now go before the European Commission for final regulatory sign-off.