ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

On May 18, 2021, Roche announced that its cobas® SARS-CoV-2 Test received Emergency Use Authorization (EUA) from the FDA for testing asymptomatic individuals, expanding COVID-19 testing to help reduce virus spread. The test can process pooled samples of up to six individuals, supporting CDC guidance amid findings that asymptomatic individuals account for over half of COVID-19 transmissions. Roche previously enabled 160 million molecular tests in 2020 and continues to innovate in diagnostics, emphasizing public health and the safe reopening of communities.

Roche announced new findings from 19 cancer treatments to be presented at the 2021 ASCO Annual Meeting, scheduled for June 4-8, 2021. The data emphasizes patient-centric approaches, particularly for early-stage non-small cell lung cancer (NSCLC) through Tecentriq, which improves disease-free survival. Roche also highlights tumor-agnostic therapies and data in breast and blood cancer treatments. Significant studies, including ALPHA-T and TAPISTRY, focus on personalized care and decentralized trials. Roche aims to enhance treatment accessibility and equity in oncology.

Roche's Tecentriq (atezolizumab) has received European Commission approval as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) exhibiting high PD-L1 expression. This decision presents an alternative to chemotherapy for eligible patients and represents Tecentriq's fourth indication in metastatic NSCLC and fifth in lung cancer overall within the EU. The approval is based on the Phase III IMpower110 study, demonstrating a significant overall survival improvement of 7.1 months compared to chemotherapy. Roche's development program for Tecentriq continues to expand across various cancer types.

Genentech announced that the FDA Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq (atezolizumab) for treating adults with locally advanced or metastatic urothelial carcinoma not eligible for cisplatin chemotherapy and with high PD-L1 expression. This meeting is part of an industry review of accelerated approvals. The FDA has yet to announce a final decision. Tecentriq, approved since 2017, has shown significant efficacy for specific bladder cancer patients, with ongoing studies in various cancers.

On April 28, 2021, Roche (OTCQX: RHHBY) announced that the FDA's Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq® for metastatic bladder cancer patients not eligible for cisplatin chemotherapy. This endorsement highlights the significant unmet medical need in this patient population. Roche is committed to advancing Tecentriq's clinical development, having received a similar positive recommendation for triple-negative breast cancer. The FDA's final decision on Tecentriq is pending.

On April 28, 2021, Roche announced five new intended uses for its cardiac biomarkers, Elecsys® cTnT-hs and NT-proBNP, enhancing cardiovascular disease diagnosis and management.

These biomarkers aim to identify cardiovascular risks, improve early diagnosis, and support timely treatments, potentially reducing healthcare costs. Notably, new applications include assessing risks for patients with type-2 diabetes and Atrial Fibrillation.

With over 200 million adults undergoing major non-cardiac surgery annually, these innovations could help predict heart attack risks in surgical patients.

Genentech announced that the FDA's Oncologic Drugs Advisory Committee voted 7 to 2 to maintain the accelerated approval of Tecentriq (atezolizumab) in combination with chemotherapy for adults suffering from unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) expressing PD-L1. While the committee's recommendation is significant for treatment accessibility, the continued approval is contingent upon further collaboration with the FDA, particularly after the IMpassion131 study failed to meet its primary endpoint. Genentech remains focused on further developing Tecentriq for various cancers.

On April 28, 2021, Roche announced that the FDA Oncologic Drugs Advisory Committee voted 7 to 2 to maintain the accelerated approval of Tecentriq (atezolizumab) with chemotherapy for treating adults with triple-negative breast cancer (mTNBC) expressing PD-L1. The decision follows an industry review of accelerated approvals with unmet primary endpoints. While Tecentriq was initially approved in March 2019 based on positive PFS results, its continued approval hinges on subsequent study results. Roche aims to collaborate with the FDA on next steps for Tecentriq.

Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended ENSPRYNG (satralizumab) for the treatment of anti-aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder (NMOSD) in adults and adolescents aged 12 and older. If approved, it will be the first subcutaneous treatment option available in the EU for this condition. ENSPRYNG has shown significant efficacy in reducing relapse rates in pivotal Phase III trials, demonstrating a favorable safety profile. A final decision from the European Commission is anticipated soon.