FDA Approves Genentech’s GAZYVA for Lupus Nephritis
Genentech, a member of the Roche Group, announced that the FDA has approved GAZYVA (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The approval is supported by data from the Phase II NOBILITY and Phase III REGENCY studies, where GAZYVA demonstrated superiority over standard therapy alone, becoming the first anti-CD20 monoclonal antibody to show a complete renal response benefit in a randomized Phase III LN trial.
“The FDA’s approval of GAZYVA offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure,” said Louise Vetter, President and CEO of the Lupus Foundation of America.
In the REGENCY study, nearly 46.4% of patients receiving GAZYVA with standard therapy achieved a complete renal response, compared to 33.1% with standard therapy alone. These results were accompanied by improvements in key disease markers, including complement levels and proteinuria, and reduced corticosteroid use. The safety profile of GAZYVA remained consistent with its known use in hematology-oncology settings.
“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,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech. “This approval marks a significant step toward a potential new standard of care.”
Lupus nephritis affects over 1.7 million people globally, predominantly women of color and of childbearing age. Up to one-third of untreated patients may progress to end-stage kidney disease. GAZYVA offers a more convenient dosing regimen, following four initial doses in the first year, it can be administered twice yearly with an optional 90-minute infusion after the first dose. The therapy was granted Breakthrough Therapy Designation in 2019 and is also under regulatory review in Europe.
Glaukos’ EPIOXA Wins FDA Approval for Keratoconus Treatment
The FDA has approved EPIOXA (EPIOXA HD / EPIOXA), developed by Glaukos Corporation, as the first and only incision-free, topical drug therapy for keratoconus. This groundbreaking advancement introduces a new standard of care for a rare, sight-threatening condition that has long been underdiagnosed and undertreated. EPIOXA is designed to eliminate the need for epithelium removal during corneal cross-linking, offering a less invasive, more comfortable alternative to existing therapies.
“The FDA approval of EPIOXA ushers in a new standard-of-care for patients suffering from keratoconus,” said Thomas Burns, Glaukos Chairman and CEO. “EPIOXA is designed to significantly improve patient comfort and minimize recovery time, representing a game-changing new treatment. This marks a major milestone in our mission to improve access to sight-saving therapies.”
The approval is based on data from two Phase III pivotal trials involving more than 400 patients. Both trials met their primary efficacy endpoints and demonstrated strong safety and tolerability profiles. EPIOXA uses a dual-formulation, oxygen-enriched system activated by UV light, which enables the therapeutic effect without damaging the eye’s surface.
“Keratoconus is underdiagnosed and often untreated due to the invasive nature of current options,” said Dr. W. Barry Lee, corneal specialist and President of the Cornea Society. “An incision-free treatment like EPIOXA that preserves the epithelium can address key patient concerns around pain and recovery.”
Glaukos plans to launch EPIOXA commercially in Q1 2026, alongside broad initiatives to improve patient awareness, access, and early diagnosis. These include co-pay assistance programs, patient education strategies, and screening campaigns to address the significant unmet needs in the keratoconus patient community.
FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma
Replimune Group, Inc. announced that the FDA has accepted its Biologics License Application (BLA) resubmission for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy. The agency has set a PDUFA date of April 10, 2026, following a Class II resubmission timeline.
“We are pleased the agency has accepted the resubmission of our BLA for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. “RP1 plus nivolumab offers a strong risk-benefit profile where there are few options for patients with advanced melanoma. We look forward to working with the FDA to expedite the review process.”
Replimune’s resubmission follows months of engagement with the FDA to address feedback outlined in a Complete Response Letter (CRL) issued in July 2025. The updated submission includes additional data, analyses, and information intended to support the potential approval of RP1 as a treatment option in this high-need patient population.
The company continues to advance its oncolytic immunotherapy platform, with RP1 representing a novel approach that combines direct tumor killing with immune activation.
Cogent’s Bezuclastinib Earns FDA Breakthrough Therapy for SM-AHN
Cogent Biosciences announced that the FDA has granted Breakthrough Therapy Designation to bezuclastinib for the treatment of NonAdvanced Systemic Mastocytosis (NonAdvSM) in patients previously treated with avapritinib, as well as those with Smoldering Systemic Mastocytosis, both populations with no approved standard of care.
“We are excited to announce Breakthrough Therapy Designation for bezuclastinib, which highlights the FDA’s recognition of the unmet need in NonAdvSM and the potential for this therapy to redefine treatment,” said Andrew Robbins, President and CEO of Cogent Biosciences. “We had a productive pre-NDA meeting with the agency and are on track to submit our NDA by the end of 2025.”
The designation was based on positive results from the Phase III SUMMIT trial, in which bezuclastinib met all primary and key secondary endpoints and demonstrated consistent benefit in high-need subgroups. Top-line data were shared in July 2025, and full results will be presented at an upcoming scientific conference later this year.
Breakthrough Therapy Designation streamlines the path to approval by providing eligibility for Priority Review, rolling submissions, and increased FDA engagement. Cogent is preparing for a potential commercial launch, supported by this designation and the strong efficacy data from SUMMIT.
Amgen’s TEZSPIRE Gets FDA Nod for Chronic Rhinosinusitis with Nasal Polyps
AstraZeneca and Amgen announced that the FDA has approved TEZSPIRE (tezepelumab) as an add-on maintenance treatment for adults and adolescents (12+) with chronic rhinosinusitis with nasal polyps (CRSwNP) who remain inadequately controlled. TEZSPIRE is now the first and only biologic targeting thymic stromal lymphopoietin (TSLP) approved for this indication, expanding its reach beyond severe asthma.
“This approval introduces an innovative treatment option for patients, helping to break the cycle of debilitating symptoms, repeat surgeries, and steroid use,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America.
The approval is supported by results from the Phase III WAYPOINT trial, where TEZSPIRE demonstrated significant reductions in nasal polyp size, need for surgery, and systemic corticosteroid use, with sustained symptom improvement. The safety profile was consistent with previous indications, with the most common adverse events being COVID-19, nasopharyngitis, and upper respiratory infections.
“Today’s approval expands TEZSPIRE’s use to another epithelial-driven inflammatory condition, reinforcing its unique mechanism of action across upper and lower airways,” said Ruud Dobber, EVP, BioPharmaceuticals, AstraZeneca. Regulatory reviews are ongoing in the EU, China, Japan, and other markets following a recent positive CHMP opinion.
