Articles tagged with 'Cancer' | Bayer

Late-stage development programs with significant potential to drive long-term growth / New R&D strategy and operating model sharpening innovation focus and strengthening early development pipeline in oncology, cardiovascular, neurology & rare disease...

Phase III study ARASTEP initiated in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline / Fifth major cl...

Nubeqa™ now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer / Additional indication based on data from the pivotal Phase III ARASENS trial ...

European Commission granted approval of Nubeqa™ (darolutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) / Approval is based on Phase III ARASENS trial data...

Darolutamide approved for metastatic prostate cancer as well as non-metastatic castration-resistant prostate cancer / New approval based on data from the pivotal Phase III ARASENS trial 

New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS) and improved key clinically relevant endpoints in patients with various t...

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel alone, with sim...

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

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...

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...

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 (...

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 ...

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...

Application is being reviewed concurrently among participating international health authorities under the FDA Oncology Center of Excellence’s (OCE) Project Orbis initiative

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 ...

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 ...

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...

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...

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 ...

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...

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...

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...

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...

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 ...

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...

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...

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...

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...

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...

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...