Articles tagged with 'Cancer' | Bayer

Newsroom Bayer (Cancer)

2022
September
11,
2022
| 10:15 AM Europe/Amsterdam
Consistent benefits were also seen in other patient-relevant endpoints, including all-cause and prostate cancer-related death and cumulative incidence of adverse events (AEs) of special interest...
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August
30,
2022
| 14:00 PM Europe/Amsterdam
In prostate cancer, a key therapeutic area for Bayer, new patient-relevant data from the ARASENS Phase III study in metastatic hormone-sensitive prostate cancer (mHSPC) will be showcased, as well as data from the RALU study comprising real-world evid...
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August
08,
2022
| 08:30 AM Europe/Amsterdam
Darolutamide now has indications in both non-metastatic castration-resistant prostate cancer (nmCRPC) for men at high risk of developing metastatic disease and metastatic hormone-sensitive prostate cancer (mHSPC) / Today’s approval under the FDA’s Re...
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July
04,
2022
| 09:00 AM Europe/Amsterdam
New subgroup analysis from Phase III ARASENS trial in patients with metastatic hormone-sensitive prostate cancer (mHSPC), shows that darolutamide plus androgen deprivation therapy (ADT) and docetaxel provides consistently favorable overall survival (...
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June
21,
2022
| 12:00 PM Europe/Amsterdam
Berlin, June 21, 2022 - The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with ...
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May
19,
2022
| 14:00 PM Europe/Amsterdam
Prostate cancer remains a key focus area with darolutamide data in non-metastatic castration-resistant prostate cancer (high-risk nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), and radium-223 dichloride research in metastatic castr...
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May
03,
2022
| 14:00 PM Europe/Amsterdam
Application is being reviewed concurrently among participating international health authorities under the FDA Oncology Center of Excellence’s (OCE) Project Orbis initiative...
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March
11,
2022
| 07:30 AM Europe/Amsterdam
Submission to the Ministry of Health, Labor and Welfare (MHLW) in Japan for an additional indication of darolutamide in prostate cancer with distant metastases / Application is based on data from the pivotal Phase III ARASENS trial, in which the use ...
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March
09,
2022
| 07:30 AM Europe/Amsterdam
Submissions in the U.S. and European Union (EU) for an additional indication in patients with metastatic hormone-sensitive prostate cancer (mHSPC) / Submissions are based on data from the pivotal Phase III ARASENS trial recently published in The New ...
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February
17,
2022
| 22:33 PM Europe/Amsterdam
Raise in peak sales expectations follows presentation of positive Phase III trial ARASENS with darolutamide (Nubeqa) in metastatic hormone-sensitive prostate cancer at 2022 ASCO GU Cancers Symposium and publication in The New England Journal of Medic...
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February
17,
2022
| 22:32 PM Europe/Amsterdam
Results from the Phase III ARASENS trial evaluating darolutamide plus androgen deprivation therapy (ADT) and docetaxel showed a statistically significant increase in overall survival with a reduction in the risk of death by 32.5% compared to ADT plus...
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2021
December
03,
2021
| 07:30 AM Europe/Amsterdam
ARASENS trial demonstrates an increase in overall survival evaluating darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) compared to docetaxel and ADT, a standard of care in metastatic hormone-sensitive prostate cancer ...
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October
29,
2021
| 10:00 AM Europe/Amsterdam
Berlin, October 29, 2021 - The European Patent Office has reversed a first instance decision and maintained a Bayer patent (EP 1 845 961) on the once-daily administration of rivaroxaban (Xarelto™; 10, 15 and 20 mg). The 2.5 mg dose is not affected.Se...
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September
16,
2021
| 08:30 AM Europe/Amsterdam
In an updated analysis on the adult subset of non-central nervous system (CNS) / TRK fusion cancer patients from three larotrectinib clinical trials, a high overall response rate (ORR) of 67% with a median duration of response (mDoR) of 49.3 months w...
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September
09,
2021
| 14:00 PM Europe/Amsterdam
Updated analyses for Vitrakvi™ (larotrectinib) reaffirm sustained clinical benefits for patients with TRK fusion cancer / Breadth of prostate cancer portfolio on display, including presentations for Nubeqa™ (darolutamide) in non-metastatic castration...
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August
24,
2021
| 14:00 PM Europe/Amsterdam
Patients after recent lower-extremity revascularization due to symptomatic PAD now included in the label in the US / Xarelto plus aspirin is the first treatment approach indicated in the US for both coronary artery disease (CAD) and PAD, now includin...
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June
21,
2021
| 14:00 PM Europe/Amsterdam
In the US, Bayer has filed for relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL) / In the EU, Bayer has filed for relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted / Filings based on results from Phase ...
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May
25,
2021
| 08:30 AM Europe/Amsterdam
Berlin, May 25, 2021 - Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval of larotrectinib in China for the treatment of...
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May
19,
2021
| 23:00 PM Europe/Amsterdam
Larotrectinib achieved 75% (95% CI 68-81) overall response rate (ORR) and median duration of response (DoR) of 49.3 months (95% CI 27.3-not estimable [NE]) in expanded integrated dataset of 206 evaluable adults and children with TRK fusion cancer, wh...
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May
11,
2021
| 14:00 PM Europe/Amsterdam
Updated long-term efficacy and safety data of larotrectinib (Vitrakvi™) for patients with TRK fusion cancer from an integrated dataset, sub-analyses for TRK fusion cancer patients with primary central nervous system (CNS) tumors and lung cancer, resp...
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May
10,
2021
| 14:00 PM Europe/Amsterdam
New prespecified exploratory analysis from the FIDELIO-DKD study data provides insight into the efficacy of finerenone on new onset atrial fibrillation or flutter (AFF) in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) / New VOY...
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April
10,
2021
| 14:30 PM Europe/Amsterdam
Copanlisib is the first and only PI3K inhibitor to demonstrate broad and superior efficacy in combination with rituximab in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL) compared to rituximab and placebo / Phase III trial CHRONOS-3 sh...
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April
06,
2021
| 14:00 PM Europe/Amsterdam
Oral presentation in a Clinical Trials Plenary Session on April 10 to highlight the Phase III trial CHRONOS-3 evaluating copanlisib (Aliqopa™) plus rituximab compared to rituximab and placebo in relapsed indolent non-Hodgkin’s Lymphoma (iNHL) / New d...
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March
23,
2021
| 15:15 PM Europe/Amsterdam
Precision oncology treatment Vitrakvi™ (larotrectinib) approved for the treatment of NTRK fusion-positive advanced or recurrent solid tumors / In clinical studies, larotrectinib demonstrated high response rates and durable responses in adults and chi...
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February
08,
2021
| 23:00 PM Europe/Amsterdam
New analyses from the Phase III ARAMIS trial further strengthen the overall survival benefit and favorable safety profile of darolutamide (Nubeqa™) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) / Additional data from darolu...
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February
08,
2021
| 13:00 PM Europe/Amsterdam
Phase III study ARANOTE to be initiated in metastatic hormone-sensitive prostate cancer (mHSPC) assessing the novel androgen-receptor antagonist in combination with standard androgen deprivation therapy / Start of patient enrollment expected by the e...
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February
03,
2021
| 09:30 AM Europe/Amsterdam
Berlin, February 3, 2021 - The Chinese National Medical Products Administration (NMPA) has approved Nubeqa™ (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of develop...
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2020
November
18,
2020
| 08:30 AM Europe/Amsterdam
Focus on fostering development of integrated healthcare solutions in fields of cardiometabolic and renal diseases, oncology, and women’s health / Germany’s Federal Minister of Health Jens Spahn to give keynote at the virtual digital health forum "G4A...
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October
26,
2020
| 13:30 PM Europe/Amsterdam
FDA submission based on results from Phase III VOYAGER PAD study which showed a significant reduction in the primary efficacy endpoint in patients after lower-extremity revascularization due to symptomatic peripheral artery disease (PAD) / There is c...
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October
23,
2020
| 23:15 PM Europe/Amsterdam
The companion diagnostic (CDx) approval is part of the global collaboration between Bayer and Foundation Medicine, Inc. for the development and commercialization of next-generation sequencing (NGS)-based companion diagnostics in oncology / Detection ...
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