Roche Hldg Stock Price, News & Analysis

On June 9, 2022, Roche received approval from the European Commission for Tecentriq (atezolizumab) as an adjuvant treatment for adults with high-risk non-small cell lung cancer (NSCLC) following surgery and chemotherapy. This approval marks Tecentriq as the first cancer immunotherapy approved in Europe for early-stage NSCLC. In the Phase III IMpower010 trial, Tecentriq demonstrated a 57% reduction in the risk of disease recurrence or death, making it a significant advancement in lung cancer treatment. Roche plans further studies to analyze overall survival data.

The European Commission has granted conditional marketing authorization for Lunsumio® (mosunetuzumab), a bispecific antibody for treating adult patients with relapsed or refractory follicular lymphoma (FL). Based on the phase I/II GO29781 study, Lunsumio showed a 60% complete response rate and an 80% objective response rate, with the majority of responses lasting at least 18 months. This treatment is a chemotherapy-free, off-the-shelf option, potentially transforming FL management. Over 28,000 new FL cases are diagnosed annually in Europe.

Roche has received FDA approval for a label extension of Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in babies under two months. This decision is based on positive interim results from the RAINBOWFISH study, showing that most pre-symptomatic infants treated for a year achieved significant motor milestones, such as sitting, standing, and walking. Additionally, updated prescribing information reflects promising data from the FIREFISH study, indicating that symptomatic infants treated for two years can also meet key motor milestones.

Roche (OTCQX: RHHBY) announced pivotal data from the NP30179 expansion study of glofitamab at ASCO and EHA 2022, showing a 39.4% complete response rate in patients with heavily pre-treated diffuse large B-cell lymphoma (DLBCL) after a median follow-up of 12.6 months. Glofitamab offers a fixed-duration treatment approach, with 77.6% of responses being durable at 12 months. The drug is part of Roche's bispecific antibody development program, aimed at enhancing treatment for blood cancers. Submissions for regulatory approval to the EMA and FDA are planned this year.

Genentech announced new pivotal data on its investigational CD20xCD3 bispecific antibody, glofitamab, to be presented at ASCO and EHA 2022. Following a median 12.6-months follow-up, 39.4% of heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL) achieved a durable complete response, with 51.6% showing overall response. Glofitamab, given as a fixed-duration treatment, may improve outcomes for patients facing limited options. Regulatory submissions are being planned to EMA and FDA for approval.

Roche has received European Commission approval for Polivy (polatuzumab vedotin) in combination with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). This first new treatment in over 20 years demonstrates a significant improvement in progression-free survival over the standard R-CHOP regimen, with a 27% reduction in disease progression risk. The approval was grounded in the pivotal POLARIX study results, showing comparable safety profiles. Roche aims to alleviate DLBCL burdens on patients and healthcare systems.

Roche and its subsidiary TIB Molbiol have launched three LightMix® Modular Virus kits designed for the detection of the monkeypox virus amid rising cases in non-endemic countries. The kits will aid in assessing the spread of the virus and support public health measures. The first kit detects orthopoxviruses, while the second targets only monkeypox viruses. A third kit simultaneously identifies both, enhancing research capabilities. These test kits will be available for research use globally.

Roche (OTCQX: RHHBY) announced significant findings to be presented at the 2022 ASCO Annual Meeting, focusing on innovative cancer treatments. Key highlights include data on glofitamab, a bispecific antibody designed for aggressive lymphoma, and its phase II trial results. Further presentations will cover genomic testing in cancer treatment, as well as updates on various oncology therapies, showcasing Roche's commitment to advancing personalized cancer care and improving patient outcomes.

Roche (OTCQX: RHHBY) has partnered with The Global Fund to enhance diagnostic capabilities in low- and middle-income countries (LMICs), targeting infectious diseases like tuberculosis (TB) and HIV. The collaboration aims to improve access to diagnostics, helping millions of undiagnosed individuals. Currently, about 2 billion people are estimated to have TB, with a significant portion of TB fatalities occurring in LMICs. The COVID-19 pandemic has further disrupted healthcare programs, intensifying the need for immediate action in diagnostics to save lives.