Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
- About 90,000 women globally die from endometrial cancer each year1
- VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI (dostarlimab-gxly)
- Roche/GSK collaboration represents an important step towards a personalised healthcare strategy that can help identify patients who are most likely to benefit from a specific therapy
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.
Endometrial cancer is the most common gynecologic cancer in the U.S. and the fourth most common cancer in women in North America.2 In addition, about 90,000 women globally die from endometrial cancer each year.1 There are limited treatment options for women whose disease progresses on or after first-line therapy and this is the first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy.
“We are excited to launch this companion diagnostic test with GSK to help recurrent or advanced endometrial cancer patients with limited treatment options,” said Thomas Schinecker, CEO of Roche Diagnostics. “This test provides clinicians with an effective tool to identify patients best suited for treatment with GSK’s JEMPERLI, providing a new therapeutic option for women with MMR-deficient endometrial cancer whose disease progresses on or following initial chemotherapy treatment.”
MMR deficiency is most common in endometrial cancer. This companion diagnostic (CDx) provides clinicians with a standardised testing option that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers tested by immunohistochemistry (IHC). FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.
About the VENTANA MMR RxDx Panel
The VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market VENTANA MMR IHC Panel. VENTANA MMR RxDx Panel is a qualitative immunohistochemistry test intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue by light microscopy. The OptiView DAB IHC Detection Kit is used for MLH1, MSH2 and MSH6, and the OptiView DAB IHC Detection Kit with the OptiView Amplification Kit is used for PMS2 on a VENTANA BenchMark ULTRA instrument. DNA mismatch repair (MMR) proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.3,4,5 PD-1 inhibitors can be effective in cancers with a high frequency of MMR deficiency and/or microsatellite-instability, high (MSI-H) including endometrial cancer.3,5 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. 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 www.roche.com.
All trademarks used or mentioned in this release are protected by law.
 Bray F, Ferlay J, et al, Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. (2018) 68:394–424. 10.3322/caac.21492
 Lortet-Tieulent J, J Ferlay, F Bray, and A Jemal. (2018) International patterns and trends in endometrial cancer incidence, 1978-2013. J Natl Cancer Inst. 110, 354-361.
 Lee YC, S Lheureux, and AM Oza. (2017) Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 29, 47-58.
 GSK website, https://www.gsk.com/en-gb/media/press-releases/data-from-garnet-study-indicates-robust-activity-of-dostarlimab-in-patients-with-advanced-or-recurrent-endometrial-cancer/
 Kato M, Takano M, Miyamoto M, et al. DNA mismatch repair-related protein loss as a prognostic factor in endometrial cancers. J Gynecol Oncol. 2015:26(1):40-45.
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: firstname.lastname@example.org
| Dr. Nicolas Dunant|
Phone: +41 61 687 05 17
| Patrick Barth|
Phone: +41 61 688 44 86
| Dr. Daniel Grotzky |
Phone: +41 61 688 31 10
| Karsten Kleine|
Phone: +41 61 682 28 31
| Nina Mählitz|
Phone: +41 79 327 54 74
| Nathalie Meetz|
Phone: +41 61 687 43 05
| Dr. Barbara von Schnurbein|
Phone: +41 61 687 89 67
|Roche Investor Relations|
| Dr. Karl Mahler|
Phone: +41 61 68-78503
| Jon Kaspar Bayard|
Phone: +41 61 68-83894
| Dr. Sabine Borngräber|
Phone: +41 61 68-88027
| Dr. Bruno Eschli|
Phone: +41 61 68-75284
| Dr. Birgit Masjost|
Phone: +41 61 68-84814
| Dr. Gerard Tobin|
Phone: +41 61 68-72942
|Investor Relations North America|
| Loren Kalm|
Phone: +1 650 225 3217
| Dr. Lisa Tuomi|
Phone: +1 650 467 8737
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Underskott för staten i april 20217.5.2021 09:30:00 CEST | Pressemelding
Underskott för staten i april 2021 Statensbetalningar resulterade i ett underskott på 16,9miljarder kronor i april. Riksgäldens prognosvar ett underskottpå 24,9 miljarder kronor.Statens skatteinkomster var något högre än förväntat samtidigt som Riksgäldens nettoutlåning var lägre. Det primära saldot var 5,4 miljarder kronor högre än prognos. Det beror främst på att skatteinkomsterna var cirka 4 miljarder kronor högre än beräknat. Riksgäldens nettoutlåning till myndigheter m.fl. var 3,5 miljarder kronor lägre än prognos. Det beror på högre inlåning från ett antal myndigheter. Räntebetalningarna på statsskulden var 0,8 miljarder kronor högre än prognos. För tolvmånadersperioden till och med april 2021 visade statens betalningar ett underskott på 148,1 miljarder kronor. Statsskulden uppgick till 1 226 miljarder kronor i slutet av april. Utfallet för maj 2021 publiceras den 7 juni kl. 09.30. Nya prognoser för 2021 och 2022 publiceras den 27 maj, kl. 09.30. Kontakt Pressfunktionen, 08 613 4
Deficit for Swedish central government in April 20217.5.2021 09:30:00 CEST | Press release
Deficitfor Swedish central government in April2021 Swedish central government payments resulted in a deficitof SEK 16.9 billion inApril. The Debt Office's forecast was a deficitof SEK 24.9 billion.Central government tax income were slightly higher than expected, while the Debt Office's net lending was lower. The primary balance was SEK 5.4 billion higher than the forecast. This was mainly due to tax income being approximately SEK 4 billion higher than calculated. The Debt Office’s net lending to government agencies etc. was SEK 3.5 billion lower than forecasted. This is explained by higher deposits by a number of government agencies. Interest payments on central government debt were SEK 0.8 billion higher than the forecast. For the twelve-month period up to the end of April 2021, central government payments resulted in a deficit of SEK 148.1 billion. Central government debt amounted to SEK 1 226 billion at the end of April. The outcome for May 2021 will be published on June 7 at 9.30 a
Nexstim Receives a New NBS System Order from a Leading California Based Academic Hospital7.5.2021 09:00:00 CEST | Press release
Press release,Helsinki, 7.5.2021 at 10:00 AM(EEST) Nexstim Receives a New NBS System Order from a Leading California Based AcademicHospital Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company") announces that it has received an NBS system order from a distinguished academic hospital based in Northern California, US. Nexstim NBS systems use the unique SmartFocus® TMS technology that enables accurate stimulation of the targeted area in the brain. The Nexstim NBS system is the only FDA cleared system based on navigated Transcranial Magnetic Stimulation (nTMS) for non-invasive mapping of the speech and motor cortices of the brain. Mikko Karvinen, CEO of Nexstim, says: “We are happy to announce the sale of this new NBS system to a renownedacademic hospital. The NBS business has been a stable source of revenue for us during the COVID-19 pandemic, and we are glad to see an increasing number of patients benefiting from our SmartFocus® TMS technology as the system will be used for motor a
HOYLU MOTTAGER ORDER FRÅN STOR BYGGFIRMA I USA7.5.2021 08:45:00 CEST | Pressemelding
Stockholm den 7 maj 2021 – Hoylu, ledande inom visuella samarbetslösningar för distribuerade team, meddelade idag att man fått en order från Barton Malow, (www.bartonmalow.com), ett fullservice entreprenad företag med huvudkontor i Michigan, USA. Ordervärdet uppgår till 340 000 sek och representerar expansionen av Hoylus verksamhet inom byggbranschen med high-end arkitektonisk design och projektledning. För ytterligare information, vänligen kontakta: Stein Revelsby, VD på Hoylu + 1 213 440 2499 e-post: email@example.com Karl Wiersholm, CFO på Hoylu + 1 425 829 2316 e-post: firstname.lastname@example.org Om Hoylu Hoylus uppdrag är att göra distansarbete och informationsutbyte enkelt. Genom vår anpassningsbara Connected Workspaces™ levererar vi programvarulösningar till företag, organisationer och individer i praktiskt taget alla branscher som gör det möjligt för alla team, stora som små att arbeta effektivt och säkert i ett intuitivt och enkelt arbetsflöde. För mer information: www.hoylu.com Testa Hoylu grati
HOYLU RECEIVES ORDER FROM LARGE CONSTRUCTION FIRM IN THE US7.5.2021 08:45:00 CEST | Press release
Stockholm, Sweden, May 7, 2021 – Hoylu, a leader in visual collaboration solutions for distributed teams, announced today that it has received an order from Barton Malow, (www.bartonmalow.com), a full-service construction firm headquartered in Michigan, US. The order value is 340,000 SEK and represents an expansion of Hoylu’s business within the construction industry with high-end architectural design and project management. For more information, please contact: Stein Revelsby, CEO at Hoylu +1 213 440 2499 Email: email@example.com Karl Wiersholm, CFO at Hoylu +1 425 829 2316 Email: firstname.lastname@example.org About Hoylu Hoylu’s mission is to empower distributed teams to collaborate easily and seamlessly while always staying in sync. Hoylu’s Connected Workspaces™ helps enterprises as well as small and medium companies run projects, programs, and initiatives across time zones and continents with the same level of engagement and clarity as if everyone were working in the same room. For more information: www
Dlab partner in European digital transformation project for a more sustainable energy system7.5.2021 08:30:00 CEST | Press release
Cleantech company Dlaboratory Sweden AB (publ) joins a European consortium in applying for funds from EU’s joint programming platform ERA-NET Smart Energy Systems (SES) for a project on power grid resilience. The overall aim of the project is to advance the green energy transition in all sectors of the energy system while also ensuring security of supply in the power grid. Swedish KTH Royal Institute of Technology, Austrian Institute of Technology (AIT), Siemens, Wiener Netze, Fraunhofer ISE, OFFIS, and Solandeo GmbH join forces with dLab for the ERA-Net SES call for transnational projects on digital transformation for green energy transition. The proposed project called Resili8 – Resilience for Cyber-Physical Energy Systems – is aiming to increase grid resilience through a digitalized smart system. Part of the project proposal plan is an installation of dLabs solution in Austrian utilities company Wiener Netze’s power grid to study improved resilience possibilities. - The future energ
Yara International ASA ex-dividend NOK 20 today7.5.2021 08:01:00 CEST | Press release
Oslo, 7 May 2021: Shares in Yara International ASA will be traded ex-dividend NOK 20 as of today, 7 May 2021. Contact Thor Giæver, Investor Relations Cellular: (+47) 480 75 356 E-mail: email@example.com About Yara Yara grows knowledge to responsibly feed the world and protect the planet. Supporting our vision of a world without hunger and a planet respected, we pursue a strategy of sustainable value growth, promoting climate-friendly crop nutrition and zero-emission energy solutions. Yara’s ambition is focused on growing a climate positive food future that creates value for our customers, shareholders and society at large and delivers a more sustainable food value chain. To achieve our ambition, we have taken the lead in developing digital farming tools for precision farming, and work closely with partners throughout the food value chain to improve the efficiency and sustainability of food production. Through our focus on clean ammonia production, we aim to enable the hydrogen econo