Sapporo Medical University

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

Retrieved on: 
Tuesday, April 2, 2024
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The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer

Retrieved on: 
Monday, February 19, 2024
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Metabolism, Immunotherapy, AstraZeneca, News, Daiichi Sankyo, National Cancer Institute, Lung cancer, Triple-negative breast cancer, Immunology, Patient, Cleavage, Biopharmaceutical, Social media, Progression-free survival, Treatment, BLA, Docetaxel, IHC, DXD, Pharmacotherapy, NSCLC, Breast cancer, Gefitinib, PD-1, Safety, Lung, Pemetrexed, PFS, American Cancer Society, Pircher, Observational study, MD, Sapporo Medical University, Food, Cancer, ADC, OS, Immunoglobulin G, Death, Medicine, Pharmaceutical industry

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

Key Points: 
  • AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.
  • In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favorable OS trend.
  • Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

Datopotamab Deruxtecan Met Dual Primary Endpoint of Progression-Free Survival in Patients With Advanced Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial

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Monday, July 3, 2023
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The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified.
  • Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
  • Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
  • AstraZeneca is also researching a potential diagnostic test to help identify patients most likely to benefit from treatment with datopotamab deruxtecan.

Fujitsu launches new cloud-based platform for healthcare sector in Japan, promoting personalized healthcare and drug development

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Tuesday, March 28, 2023
Insurance, Allergy, Ministry of Internal Affairs and Communications, Drug development, Information system, Process safety management, MHLW, Health informatics, Internet of things, Health Level Seven International, Communication, Internal affairs, Microsoft, FHIR, Research, Doctor of Philosophy, Problem-Oriented Medical Information System, Behavior, Sapporo Medical University, Development, Healthy Living, Data analysis, MD, Patient, Collection, Health Level 7, Diagnosis, Azure, HL7, AI, Perelman Center for Advanced Medicine, Security Technical Implementation Guide, Education, Health information exchange, Disease, Pharmaceutical industry, Medical device, Medical imaging, Nursing, Health care, Life, Health, Fujitsu

Fujitsu will offer the new platform to medical institutions and pharmaceutical companies in Japan starting March 28, 2023.

Key Points: 
  • Fujitsu will offer the new platform to medical institutions and pharmaceutical companies in Japan starting March 28, 2023.
  • "Microsoft is utilizing cloud services and AI technologies in the healthcare field and promoting the next generation standards framework HL7 FHIR.
  • Health Level Seven, Inc. is an organization dedicated to developing and promoting standards for healthcare information.
  • Health Level Seven, Inc. is an organization dedicated to developing and promoting standards for healthcare information.

HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023 - ResearchAndMarkets.com

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Wednesday, March 22, 2023
Health, Oncology, CISH, Sequela, Triple-negative breast cancer, FISH, Therapy, Cleavage, HER2, CDK, Bone metastasis, Survival, Clinical trial, Route of administration, Quality of life, Lead, Woman, ERBB2, AstraZeneca, Rated R, IHC, II, Sapporo Medical University, Combination therapy, Route, Daiichi Sankyo, Administration, US, Discovery, ET, Patient, Breast cancer, Risk, DXD, Immunoglobulin G, HR, In situ hybridization, Immunohistochemistry, ADC, Growth, Mortality, Spacecraft, Lymph node, Recurrence, News, III, SERD, DFS, Birth control, Medical imaging, Pharmaceutical industry, Dietary supplement, Fine chemical

This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape.

Key Points: 
  • This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape.
  • Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer.
  • A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines.
  • HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Fujitsu and Sapporo Medical University launch joint project to realize data portability in the healthcare field

Retrieved on: 
Monday, January 16, 2023
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As part of the joint project, Fujitsu will develop a mobile app that enables users to view healthcare data on their iPhones (4) and a cloud-based healthcare data platform to manage patients' health data.

Key Points: 
  • As part of the joint project, Fujitsu will develop a mobile app that enables users to view healthcare data on their iPhones (4) and a cloud-based healthcare data platform to manage patients' health data.
  • This project marks the first initiative in Japan to link electronic medical records with Apple's Health app under Apple's support.
  • Sapporo Medical University Hospital, the affiliated hospital of Sapporo Medical University, aims to introduce the system in April 2023.
  • Fujitsu, which has been working to standardize EHRs and develop secure cloud technologies, and Sapporo Medical University, which has been working to improve the quality of advanced medical care in the Hokkaido area, launched a joint project using healthcare data at Sapporo Medical University Hospital to realize data portability in the healthcare field.

Datopotamab Deruxtecan Showed Encouraging and Durable Efficacy in Patients with Heavily Pretreated HR Positive, HER2 Low or Negative Metastatic Breast Cancer

Retrieved on: 
Thursday, December 8, 2022
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Daiichi Sankyo and AstraZeneca have a broad clinical development program for datopotamab deruxtecan in breast cancer, including the ongoing pivotal TROPION-Breast01 phase 3 trial evaluating datopotamab deruxtecan in patients with HR positive, HER2 low or negative, inoperable or metastatic breast cancer previously treated with chemotherapy.

Key Points: 
  • Daiichi Sankyo and AstraZeneca have a broad clinical development program for datopotamab deruxtecan in breast cancer, including the ongoing pivotal TROPION-Breast01 phase 3 trial evaluating datopotamab deruxtecan in patients with HR positive, HER2 low or negative, inoperable or metastatic breast cancer previously treated with chemotherapy.
  • The dose escalation portion of the trial enrolled patients with non-small cell lung cancer (NSCLC) to assess the safety and efficacy of datopotamab deruxtecan to determine the recommended dose for expansion (6 mg/kg).
  • The dose expansion part of TROPION-PanTumor01 is enrolling several different cohorts including patients with NSCLC, triple negative breast cancer (TNBC), HR positive, HER2 low or negative breast cancer, small cell lung cancer, urothelial, gastric, pancreatic, castration-resistant prostate and esophageal cancer.
  • A comprehensive development program called TROPION is underway globally with more than 10 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple TROP2 targetable tumors, including NSCLC, TNBC and HR positive, HER2 low or negative breast cancer.

TROPION-Breast02 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Previously Untreated Metastatic Triple Negative Breast Cancer

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Monday, June 13, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Prognosis, Immunotherapy, Esophageal cancer, Large-cell lung carcinoma, HR, TNBC, Cleavage, Capecitabine, Control, Daiichi Sankyo, Doctor of Philosophy, Survival, Pharmacokinetics, Progression-free survival, Breast cancer, Senior, Oncology, HRS, ADC, Sustainable development, Paclitaxel, DXD, HER2, Breast, Cardiovascular disease, Patient, TSE, PD-1, IHC, AstraZeneca, Technology, ISH, Carboplatin, Quality of life, MD, Sapporo Medical University, Squamous cell carcinoma, Bachelor of Pharmacy, PFS, Trial of the century, Neoplasm, Recurrence, Cancer, Safety, Pharmaceutical industry, Fine chemical, Birth control, Medical imaging, Limited

Datopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Key Points: 
  • Datopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • The TROPION-Breast02 trial will build on the preliminary efficacy and safety profile seen in the relapsed or refractory triple negative breast cancer arm of the TROPION-PanTumor01 trial to evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients in the first line setting.
  • Initial results of datopotamab deruxtecan in patients with pretreated metastatic triple negative breast cancer, a group with a significant unmet need, have been encouraging, said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca.
  • We are building on these early results by moving forward with the TROPION-Breast02 trial, the second pivotal trial of datopotamab deruxtecan in breast cancer, to determine if this antibody drug conjugate may potentially be used earlier in the treatment of metastatic triple negative breast cancer.

Datopotamab Deruxtecan Continues to Show Promising Durable Response and Disease Control in Patients with Metastatic Triple Negative Breast Cancer

Retrieved on: 
Tuesday, December 7, 2021
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Three patients were not confirmed to have a target lesion per BICR and therefore had a best overall response of non-CR/non-PD.

Key Points: 
  • Three patients were not confirmed to have a target lesion per BICR and therefore had a best overall response of non-CR/non-PD.
  • ii Includes response evaluable patients who had 1 postbaseline tumor assessment or discontinued treatment.
  • iii Includes patients with an unconfirmed response but are ongoing treatment.
  • The dose expansion part of the study further assessed the safety and tolerability of datopotamab deruxtecan in patients with additional solid tumors.

TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Retrieved on: 
Thursday, November 18, 2021
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TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer.

Key Points: 
  • TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer.
  • Most patients with HR positive, HER2 negative metastatic breast cancer will inevitably progress on available treatments, including hormonal therapy and standard of care chemotherapy.
  • The TROPION-Breast01 trial will evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients with previously treated HR positive, HER2 negative advanced breast cancer previously treated with one to two lines of chemotherapy.
  • Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.