Invasive Mammary Carcinoma

Roche’s PI3K inhibitor Itovebi (inavolisib) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for advanced breast cancer. The drug has been authorised for use alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and fulvestrant hormone therapy to treat adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. The FDA’s decision was supported by positive results from the late-stage INAVO120 study, in which the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and fulvestrant alone in the first-line setting. Overall survival (OS) data was immature at the time of primary analysis, but a “clear positive trend” was observed with the triplet therapy, Roche said, adding that OS will continue to be assessed. Approximately 310,720 women are expected to be diagnosed with invasive breast cancer in the US this year. HR-positive breast cancer is the most common subtype of the disease and PIK3CA mutations, which have been linked to tumour growth, disease progression and treatment resistance, are found in approximately 40% of HR-positive metastatic breast cancers. Roche said that Itovebi will be available in the US in the coming weeks, adding that results from INAVO120 are also being submitted to other global health authorities, including the European Medicines Agency. The company’s chief medical officer and head of global product development, Levi Garraway, said: “With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation. “Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes [this] approval all the more significant.” The authorisation comes less than a month after the FDA approved Roche’s injectable monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) to treat both relapsing and primary progressive multiple sclerosis. The company was also recently granted breakthrough device designation by the US regulator for its Alzheimer’s disease blood test Elecsys pTau217, which is being developed in collaboration with Eli Lilly.

TUESDAY, Oct. 1, 2024 -- While women overall are less likely to die of breast cancer now, some alarming disparities remain, a new American Cancer Society (ACS) analysis warns. Death rates for American Indian and Alaska Native women haven't changed for the past 30 years, according to the new report. And breast cancer incidence continues to grow -- rising 1% a year between 2012-2021. The biggest increases were among women under 50 (1.4% a year) and Asian American/Pacific Islander women of any age (2.5%-2.7% per year). "These gaps need to be rectified through systematic efforts to ensure access to high-quality screening and treatment for every woman," said Dr. William Dahut , chief scientific officer for the ACS. Overall, death rates due to breast cancer have dropped 44% since 1989, saving about 517,900 lives since that time, the ACS estimates. However, breast cancer remains the leading cause of cancer death in Hispanic women and is second only to skin cancer among all U.S. women. The findings are reported in Breast Cancer Statistics 2024, the cancer society's biennial update on U.S. breast cancer trends. They were published Oct. 1 in CA: A Cancer Journal for Clinicians . "The encouraging news is breast cancer [death] rates continue to decrease, thanks to advances in early detection and treatment," said lead study author Angela Giaquinto , an associate scientist at the ACS. "But future progress may be thwarted by increasing incidence, especially among younger women, and consequences of the COVID-19 pandemic, such as delayed diagnosis due to interruptions in screening," she added in an ACS news release. Researchers project that 310,720 new cases of invasive breast cancer will be diagnosed in the United States this year and that 42,250 women will die from the disease. They also project that 2,790 men will receive a breast cancer diagnosis and 530 will die. Other takeaways: "Building upon the progress we have made in reducing breast cancer [death] rates requires ensuring more individuals have access to cancer screenings," said Lisa Lacasse , president of the American Cancer Society Action Network. She called on Congress to pass the Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act. It would reauthorize a nationwide program for early detection of breast and cervical cancer and expand its reach to more people who might otherwise not be screened. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

The Roche Digital Pathology Open Environment brings together a wide array of innovative AI-based pathology tools to help clinicians improve patient care and expand personalised healthcare. Roche is now integrating more than 20 artificial intelligence (AI) algorithms from eight new collaborators into its digital pathology open environment. AI technology helps enhance pathology with high value insights, which can benefit cancer patients through precision medicine leading to targeted treatment. TUCSON, Ariz., Sept. 9, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the expansion of its digital pathology open environment with the integration of more than 20 advanced artificial intelligence (AI) algorithms from eight new collaborators. These strategic collaborations aim to support pathologists and scientists in cancer research and diagnosis by leveraging cutting-edge AI technology. Roche expands its digital pathology open environment with more that 20 AI algorithms. The seamless integration is facilitated through Roche's navify® Digital Pathology enterprise software, an application for the pathologist's workflow, which now incorporates a diverse range of AI-driven algorithms, creating easy access to third-party innovation. These AI tools are designed to enhance pathology insights, helping benefit cancer patients through precision medicine and enabling targeted treatments. "We are excited to welcome these new collaborators into our digital pathology ecosystem," said Jill German, Head of Pathology Lab for Roche Diagnostics. "By combining our leadership in tissue diagnostics with a broad offering of state-of-the-art AI technology, we aim to revolutionise cancer research, diagnostics and treatment, ultimately helping clinicians improve the lives of patients worldwide." The collaborators are: Deep Bio: Algorithm for prostate cancer detection, grading, and tumour quantification DiaDeep: Algorithms for breast cancer biomarker quantification Lunit: Tumour proportion score (TPS) analysis for non-small cell lung cancer Mindpeak: Algorithms for breast biomarkers and pan tumour PD-L1 for lung, gastric, esophageal, bladder and breast cancers Owkin: Algorithm for the screening of microsatellite stability in colorectal cancer Qritive: Algorithms for screening and grading of prostate cancer, analysing lymph nodes for metastasis, and screening for colon cancer Sonrai Analytics: Algorithm for determining microsatellite instability (MSI) status in colorectal cancer Stratipath: Algorithm for risk profiling of invasive breast cancer With these new collaborations and integrations, Roche emphasises its commitment to improving patient outcomes and advancing personalised healthcare by providing scientists and clinicians with the resources they need to deliver precise and effective cancer diagnoses. About Roche Digital Pathology As the leading provider of pathology lab solutions, Roche delivers an end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated AI-based clinical image analysis algorithms. Roche minimises variables that can impact analysis, and it is this end-to-end development that produces the quality results healthcare providers and researchers can depend on. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented AI tools into routine clinical practice and is committed to investing in and shaping the future of pathology. The Roche Digital Pathology Open Environment* serves as a collaborative platform that brings together innovative AI-based pathology tools. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. * Some algorithms are Research Use Only and not for use in diagnostic procedures. Please consult with local markets on the regulatory status of these algorithms. Roche Media Relations Jo Lynn Garing, +1 317-363-7286 or [email protected] Logo - Video -