ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced that the FDA has accepted the supplemental Biologics License Application for Polivy (polatuzumab vedotin-piiq) in combination with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). The decision is expected by April 2, 2023. The POLARIX study showed that Polivy plus R-CHP reduced the risk of disease progression by 27% compared to R-CHOP, with a safety profile comparable to that treatment. Roche aims to establish this regimen as the new standard of care for DLBCL.

Roche announces the launch of the Elecsys IGRA SARS-CoV-2 test on August 15, 2022, in CE Mark-accepting countries. This new diagnostic tool enhances understanding of the immune response to SARS-CoV-2 infections and vaccinations, particularly for immunocompromised and high-risk patients. By detecting T-cell responses, the test supports informed clinical decisions. Roche continues to expand its COVID-19 portfolio, affirming its commitment to improving patient outcomes amid the ongoing pandemic.

Xofluza has received FDA approval as the first single-dose oral treatment for influenza in children aged five to less than 12 years. The approval includes the use of Xofluza for post-exposure prophylaxis in children following contact with infected individuals. This significant advancement underscores the importance of effective influenza antivirals, especially amid ongoing public health challenges. Clinical studies demonstrated comparable efficacy to existing treatments, with Xofluza achieving a 90% reduction in influenza risk among household contacts.

Xofluza, the first single-dose oral medicine for influenza, has been approved by the FDA for children aged five to under twelve. This includes treatment for acute uncomplicated influenza and post-exposure prophylaxis for those in contact with infected persons. The approval is based on Phase III studies demonstrating its effectiveness against influenza. Adverse events in children included vomiting and diarrhea, reported in 5% of cases. Xofluza's mechanism targets viral replication, providing an innovative solution to influenza management amidst ongoing public health challenges.

Roche has received FDA approval for a label expansion of the VENTANA MMR RxDx Panel, a pioneering diagnostic test designed to identify solid tumor patients, including those with endometrial cancer, who may benefit from Merck's KEYTRUDA immunotherapy. This companion diagnostic assesses MMR protein expression, crucial for patient-specific treatment strategies. The approval reflects Roche's commitment to personalized healthcare, enhancing treatment access for patients with various cancer types. The VENTANA panel is the first of its kind and will significantly impact targeted cancer therapies.

Roche announced that the Phase III IMscin001 study for a subcutaneous formulation of Tecentriq (atezolizumab) met its co-primary endpoints, showing non-inferior blood levels compared to intravenous infusion in patients with advanced non-small cell lung cancer (NSCLC). This formulation allows for significantly reduced administration time, taking only 3-8 minutes versus 30-60 minutes for intravenous delivery. Results will be submitted to health authorities, including the FDA and EMA, enhancing patient experience and potentially broadening treatment accessibility.

Roche (RHHBY) announced plans to present data from 41 abstracts focused on Alzheimer’s disease at the 2022 Alzheimer’s Association International Conference in San Diego from July 31 to August 4. Key highlights include findings on the investigational monoclonal antibodies gantenerumab and crenezumab, as well as the Elecsys Amyloid Plasma Panel, which recently gained FDA Breakthrough Designation. The presentations aim to enhance understanding in Alzheimer’s prevention and diagnosis, emphasizing Roche's long-term commitment to advancing therapeutic research in Alzheimer's disease.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Vabysmo (faricimab) for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). This recommendation is based on positive outcomes from four phase III trials, where over 60% of patients could extend treatment intervals to every four months while improving vision. If approved, Vabysmo will be the first new treatment mechanism in over a decade for nAMD and DME in the EU, potentially benefiting millions suffering from these conditions.

Roche will present its innovative diagnostic solutions at the 2022 AACC Scientific Meeting in Chicago, from July 24-28. The exhibit booth will showcase systems that improve lab efficiencies and patient care, including the cobas® pro and cobas® pulse solutions. Roche will also introduce the Idea Lab series, focusing on key healthcare topics such as health equity and staffing pressures. The booth will feature 18 systems and 11 interactive workshops, aiming to address current lab challenges and enhance clinical outcomes.