ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech announced the FDA’s acceptance of their Biologics License Application for glofitamab, a bispecific antibody aimed at treating relapsed or refractory large B-cell lymphoma (LBCL). If approved by July 1, 2023, it will be the first fixed-duration treatment for this aggressive cancer. In the Phase I/II NP30179 study, 40% of participants achieved complete response, with long-term remission observed. The drug is a part of an extensive bispecific antibody program, which includes the recently approved Lunsumio for follicular lymphoma.

Roche has received FDA approval for Lunsumio (mosunetuzumab-axgb), a groundbreaking treatment for adult patients with relapsed or refractory follicular lymphoma after two or more lines of therapy. This approval, based on the pivotal phase II GO29781 study, showed that 80% of patients achieved durable responses and 60% experienced complete remission. Lunsumio is the first CD20xCD3 T-cell engaging bispecific antibody approved for this indication, enabling chemotherapy-free and outpatient treatment. Continued approval is contingent upon further clinical benefit verification.

Genentech, part of the Roche Group (RHHBY), announced the FDA approval of Lunsumio (mosunetuzumab-axgb) for treating relapsed or refractory follicular lymphoma (FL) after two or more systemic therapies. This first-in-class CD20xCD3 T-cell engaging bispecific antibody offers a chemotherapy-free option with an outpatient administration. The pivotal Phase II GO29781 study revealed an 80% objective response rate and a 60% complete remission rate among heavily pretreated patients. Continued approval may depend on further confirmatory trials.

Roche has received FDA approval for Actemra (tocilizumab), the first monoclonal antibody to treat COVID-19 in hospitalized adults. This treatment targets patients on systemic corticosteroids needing oxygen support. With over one million patients treated worldwide, Actemra is now approved in more than 30 countries, marking its seventh FDA indication since 2010. The approval is based on extensive clinical trials, including the RECOVERY trial and EMPACTA trial.

Genentech, part of the Roche Group (OTCQX: RHHBY), announced that the FDA has approved Actemra (tocilizumab) for treating hospitalized adults with severe COVID-19 requiring oxygen or ventilation support. This marks Actemra as the first monoclonal antibody approved for COVID-19. Over one million patients have been treated globally with Actemra since the pandemic began, which is now authorized in over 30 countries. The approval is based on extensive clinical trials showing improved outcomes for patients receiving corticosteroids.

Roche announced that the European Medicines Agency’s CHMP recommended expanding the marketing authorization for Hemlibra (emicizumab) to include prophylaxis for moderate haemophilia A without inhibitors. This follows positive results from the HAVEN 6 study, which showed effective bleed control and a favorable safety profile. Currently, only 15% of individuals with moderate haemophilia A live a bleed-free life. If approved, Hemlibra will provide an important treatment option for approximately 14% of the haemophilia A population in the EU.

Roche has announced a collaboration with Pfizer to enhance awareness and access to COVID-19 testing and treatment options in the U.S. Their Pilot® COVID-19 At-Home Test will now feature a QR code linking to covid19knowmore.com, providing vital health information. Approximately 90% of adults find personal health information difficult to understand, making this initiative crucial as winter approaches and COVID-19 cases may surge. The at-home test is authorized for individuals aged 14 and older and boasts a sensitivity of 93.2% and specificity of 100%.

Roche (RHHBY) presented updated clinical data on its bispecific antibodies, glofitamab and Lunsumio, at the ASH 2022 meeting. Glofitamab showed promising results in heavily pre-treated large B-cell lymphoma, with 61% of patients maintaining complete responses (CR) after 12 months. Lunsumio also exhibited high efficacy in relapsed follicular lymphoma, achieving a 60% CR rate. Both treatments are designed to offer fixed-duration therapies, enhancing patient outcomes and treatment convenience. Regulatory submissions for glofitamab are ongoing in Europe and the U.S.