Rituximab

The INESSS recommendation is the latest step towards public access to Gazyva (obinutuzumab) for persons with active lupus nephritis who are receiving standard therapy [1] Provincial jurisdictions will make the final decision on public reimbursement The INESSS recommendation is the latest step towards public access to Gazyva (obinutuzumab) for persons with active lupus nephritis who are receiving standard therapy [1] Provincial jurisdictions will make the final decision on public reimbursement MISSISSAUGA, ON, June 25, 2026 - Hoffmann-La Roche Limited (Roche Canada) is pleased to share that on June 3, 2026, the Institut national d’excellence en santé et en services sociaux (INESSS) recommended Gazyva (obinutuzumab) for public reimbursement in Quebec. This recommendation is for the treatment of persons with active lupus nephritis who are receiving standard therapy.[1] This positive recommendation expands the pathway to patient access, following Canada’s Drug Agency’s positive recommendation on May 6, 2026 and Health Canada's authorization in January 2026.[2,3] In Canada, lupus affects approximately 1 in 1,000 people.[4] Among those with lupus, nearly 40% develop lupus nephritis, a kidney-specific form of systemic lupus erythematosus (SLE).[5] SLE is a broader autoimmune disease that can affect various organs, such as the skin, joints, and blood system. Lupus nephritis occurs when the immune system mistakenly attacks the kidneys, potentially leading to impaired kidney function or even kidney failure. “This positive recommendation from INESSS is an important milestone towards equitable access for patients with active lupus nephritis in Quebec,” said Simon Yunger, Vice-President, Value, Pricing and Reimbursement at Roche Canada. “This decision underscores the clear therapeutic value Gazyva delivers. Roche Canada remains fully committed to working with Quebec and all provincial and territorial jurisdictions to ensure Gazyva is made available swiftly through public drug plans.” The INESSS decision was supported by evidence from the phase III REGENCY study that showed nearly half of the participants (46.4%) on Gazyva in combination with standard therapy achieved a complete renal response compared to 33.1% on standard therapy alone.[6] Data showed a statistically significant reduction of corticosteroid use and an improvement in proteinuric response.[6] Roche Canada is delighted INESSS has recognized the clinical evidence and benefit shown by Gazyva for people in Quebec living with lupus nephritis. As the file proceeds to the pan-Canadian Pharmaceutical Alliance (pCPA) for pricing negotiations, we remain focused on securing broad public and private drug plan coverage across all provinces and territories. About Lupus Nephritis Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.[8] Lupus nephritis is characterised by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and, if left unchecked, may lead to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.[9] About Gazyva Gazyva (obinutuzumab) is a Type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.[11] In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly.[12] Data suggests that Gazyva depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.[7] Gazyva is approved for adults with lupus nephritis in Canada, the United States and European Union and in over 100 countries for various types of haematological cancers. About the REGENCY Study REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva plus standard therapy or placebo plus standard therapy. The study population was representative of the real-world population of people with lupus nephritis. About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs almost 2,000 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics division in Laval, Québec. For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn. Media Contact Jolinne Kearns Communications Manager Roche Canada 416-726-7699 mississauga.rochecanada@roche.com All trademarks used or mentioned are the property of its respective owners. References L’Institut national d’excellence en santé et en services sociaux: https://www.inesss.qc.ca/thematiques/medicaments/medicaments-evaluation-aux-fins-dinscription/extrait-davis-au-ministre/gazyva-nephrite-lupique-active-7725.html Canada's Drug Agency - L'Agence des medicaments du Canada: https://www.cda-amc.ca/obinutuzumab Roche Canada, Health Canada authorizes Gazyva® (obinutuzumab) for adults with active lupus nephritis, January 2026. Available from: https://www.rochecanada.com/media/health-canada-authorizes-gazyva-obinutuzumab-for-adults-with-active-lupus-nephritis Lupus Canada; [cited 2026 January 7]. Available from: https://www.lupuscanada.org/what-is-lupus/ Hanly JG,et al. The frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology (Oxford). 2016 Feb;55(2):252-62. Gazyva Product Monograph, January 22, 2026 Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83. Hocaoglu M et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 Apr;75(4):567-573. Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-38. Anders HJ et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42. Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Investig. 2021 Jun 15;131(12):e149095. You are now leaving the website of Hoffmann-La Roche Ltd. ("Roche Canada"). Links to all external sites are provided as a resource to our visitors. Roche Canada assumes no responsibility for the content of these sites. Roche Canada has no control over these sites and the opinions, claims or comments contained in these sites should not be attributed to Roche Canada, unless otherwise specified.

Planned ~17% workforce reduction expected to generate annualized estimated savings of approximately $10M, enhancing financial flexibility Company focused on delivering upcoming regulatory and clinical milestones, including planned LOTIS-5 sBLA submission and full LOTIS-7 data by end of 2026 LAUSANNE, Switzerland, June 24, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced a strategic reorganization to focus resources behind key value-driving initiatives in support of the ZYNLONTA® (loncastuximab tesirine-lpyl) franchise. As part of the reorganization, ADC Therapeutics plans to reduce its workforce globally by approximately 17 percent. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key clinical, regulatory and manufacturing activities while maintaining the full externally facing medical affairs and commercial footprint to support ZYNLONTA. "As we further assess the Phase 3 LOTIS-5 trial outcomes, including feedback from key medical experts, we continue to believe in the favorable overall benefit-risk profile and look forward to our pre-supplemental Biologics License Application (sBLA) meeting with the U.S. Food and Drug Administration in August," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This strategic reorganization will enable us to increase our financial flexibility as we prepare for upcoming LOTIS-5 regulatory milestones and continue building on the broader opportunity for ZYNLONTA through LOTIS-7 and support for the indolent lymphoma investigator-initiated trials (IITs). We are grateful to all of our employees for their efforts to help make a meaningful impact for patients and thank them for their important contributions to our company." The Company is preparing for a scheduled pre-sBLA meeting with the FDA in August 2026 to discuss the potential regulatory path forward for ZYNLONTA in combination with rituximab to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) following the recent topline data results from the Phase 3 LOTIS-5 trial. ADC Therapeutics expects to submit an sBLA in the fourth quarter of 2026. In addition, the Company continues to advance the ZYNLONTA franchise through the ongoing Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in 2L+ DLBCL, with data anticipated by the end of 2026, as well as through support for Phase 2 IITs exploring ZYNLONTA across indolent lymphomas. ADC Therapeutics expects the reorganization to generate annualized estimated cost savings of approximately $10 million. ADC Therapeutics estimates that it will incur one-time pre-tax charges of approximately $3 million for employee severance, benefits and related termination costs, the majority of which will be recognized in the second quarter of 2026. The Company has an expected cash runway at least into 2028. About ZYNLONTA® ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at . ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA® (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the cost and effects of the strategic restructuring and workforce reduction including our ability to achieve the estimated cost savings; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and impact of such options; our expected cash runway into at least 2028 assumes use of minimum liquidity amount required to be maintained under its loan agreement covenants; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing, results and publication of the Company's clinical trials including LOTIS-7; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACTS: Investors and Media Nicole Riley ADC Therapeutics [email protected] +1 862-926-9040 SOURCE ADC Therapeutics SA 21% more press release views with Request a Demo