ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has received FDA approval for the VENTANA ALK (D5F3) CDx Assay, a companion diagnostic that identifies ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with LORBRENA® (lorlatinib). This assay is unique as the only FDA-approved immunohistochemistry test for LORBRENA. Previous studies showed ALK-positive patients treated with ALK inhibitors can achieve nearly three years of progression-free survival, compared to seven to eight months with chemotherapy. The assay also identifies more patients suitable for anti-ALK therapy than traditional FISH testing.

Genentech has announced the voluntary withdrawal of Tecentriq® (atezolizumab) from the U.S. market for prior-platinum treated metastatic urothelial carcinoma (mUC), following FDA consultation. This decision follows the failure of the IMvigor211 study to meet its primary overall survival endpoint. Genentech emphasizes that other approved indications for Tecentriq remain unaffected. The withdrawal reflects the evolving treatment landscape and aims to uphold the integrity of the FDA's Accelerated Approval Program.

Roche (OTCQX: RHHBY) announced the voluntary withdrawal of Tecentriq® for prior-platinum treated metastatic urothelial carcinoma in the US, following FDA review. This decision stems from the IMvigor211 study's failure to meet primary endpoints, promoting Roche's adherence to the Accelerated Approval Program principles. Although disappointing, Tecentriq remains approved for other indications and continues to provide benefits across multiple cancer types. Roche assures that this action will not impact patients currently receiving treatment.

Roche (OTCQX: RHHBY) announced FDA approval of Actemra/RoActemra, a biologic therapy, for adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). This is the first biologic approved for this condition, which affects approximately 2.5 million people globally, with 80% possibly experiencing ILD. Actemra/RoActemra demonstrated a significant reduction in lung function decline compared to placebo, though the primary endpoint related to skin fibrosis was not met in trials. The safety profile was comparable to existing data, with infections being the most common adverse event.

Genentech announced FDA approval for Actemra® (tocilizumab) subcutaneous injection to slow pulmonary function decline in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). This marks the first biologic therapy approved for this condition, impacting approximately 75,000 patients in the U.S. Key findings from the focuSSced Phase III trial indicated that Actemra reduced lung function decline compared to placebo, although the primary endpoint related to skin fibrosis was not met.

Common side effects included infections, aligning with Actemra's known safety profile.

Roche has received special approval from the German Federal Institute for Drugs and Medical Devices (BfArM) for its SARS-CoV-2 Rapid Antigen Test, allowing home self-testing using a nasal swab. This test simplifies the sampling process and provides results in just 15 minutes. It will be available without prescription in pharmacies across Germany. The test demonstrated a sensitivity of 82.5% and 100% specificity compared to RT-PCR. Roche's ongoing commitment to combat COVID-19 is evident through this new offering, expanding its diagnostic portfolio and supporting healthcare systems.

Roche (RHHBY) announced that the European Medicines Agency’s CHMP supports its investigational COVID-19 antibody cocktail, casirivimab and imdevimab. This scientific opinion enables EU member states to use the treatment before formal authorization during public health emergencies. Roche, in collaboration with Regeneron, aims to distribute over 2 million doses in 2021, targeting high-risk COVID-19 patients. The cocktail is currently assessed in multiple clinical trials, with approximately 23,000 participants involved.

Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Evrysdi for treating spinal muscular atrophy (SMA) in patients aged two months and older. This recommendation is based on positive outcomes from pivotal trials: FIREFISH and SUNFISH, showcasing significant motor function improvements. With over 2,500 patients treated, Evrysdi aims to fill the therapeutic gap in SMA care. The final approval decision is expected from the European Commission in two months, affecting all EU member states and select countries.

Roche announced that data from the FIREFISH Part 1 study published in the New England Journal of Medicine shows that after 12 months of treatment with Evrysdi, 90% of infants survived without permanent ventilation. Additionally, 33% of infants could sit unsupported for at least 5 seconds, a significant motor milestone. Evrysdi, FDA-approved in August 2020 as the first oral treatment for SMA, has shown a median increase of 1.9-fold in SMN protein levels. Despite some serious adverse events, no fatalities were attributed to Evrysdi.