Eribulin

BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR

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Tuesday, April 9, 2024
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“ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.

Key Points: 
  • “ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.
  • To our knowledge, there are no effective treatment options in this patient population for whom the progression-free survival prognosis is only a few weeks.
  • BriaCell will be monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer.
  • Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study.

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

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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.

Human medicines European public assessment report (EPAR): Mevlyq, eribulin, Status: Opinion

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Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, Breast, INN, Physician, ATC, Tubulin, EMA, International, Gesellschaft mit beschränkter Haftung, Civil service commission, Microtubule, Medication package insert, Committee, Patient, Anatomy, Eribulin, Medicine, CHMP, Pharmaceutical industry

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.

Key Points: 
  • Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.
  • Since Mevlyq is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Halaven was not required.
  • Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
  • - Marketing authorisation applicant
    - YES Pharmaceutical Development Services GmbH
    - Opinion adopted
    - 14/12/2023
    - Opinion status
    - Positive

Human medicines European public assessment report (EPAR): Mevlyq, eribulin, Status: Opinion

Retrieved on: 
Monday, December 18, 2023
Medicine, Anatomy, Breast, ATC, European Commission, Eribulin, International, INN, EMA, Civil service commission, Patient, Medication package insert, Marketing, CHMP, Microtubule, Committee, Medical Subject Headings, Tubulin, Physician, Gesellschaft mit beschränkter Haftung, Instrumentation, Vaccine, Pharmaceutical industry, Generic drug, Medical imaging, Medicinal plants, Liposarcoma

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.

Key Points: 
  • Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.
  • Since Mevlyq is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Halaven was not required.
  • Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
  • - Marketing authorisation applicant
    - YES Pharmaceutical Development Services GmbH
    - Opinion adopted
    - 14/12/2023
    - Opinion status
    - Positive

Eisai Enters Into Joint Development Agreement with Blissbio for Antibody Drug Conjugate BB-1701 with Option Rights for Strategic Collaboration

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Monday, May 8, 2023
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TOKYO, May 8, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd., for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration.

Key Points: 
  • TOKYO, May 8, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd., for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration.
  • Under a license agreement signed by the two companies in 2018, Eisai has granted BlissBio global exclusive development rights for several ADCs to use eribulin as the payload.
  • Under the terms of the joint development agreement, Eisai will make upfront and development milestone payments to BlissBio, conduct a Phase II clinical trial in breast cancer, and obtain option rights to develop and commercialize BB-1701 globally, excluding Greater China (China, Hong Kong, Macau, Taiwan).
  • If all development, regulatory and sales milestones are achieved, up to a total of $2 billion USD will be paid.

Eisai to Present Preclinical and Clinical Research on Eribulin at the 2022 San Antonio Breast Cancer Symposium

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Thursday, December 1, 2022
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TOKYO, Dec 1, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (HALAVEN, "eribulin") will be presented during the 2022 San Antonio Breast Cancer Symposium (SABCS), which is taking place virtually and in-person in San Antonio, Texas from December 6-10.

Key Points: 
  • TOKYO, Dec 1, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (HALAVEN, "eribulin") will be presented during the 2022 San Antonio Breast Cancer Symposium (SABCS), which is taking place virtually and in-person in San Antonio, Texas from December 6-10.
  • Eisai will present five eribulin-related abstracts, including a post hoc subgroup analysis from two pivotal Phase 3 studies (EMBRACE and Study 301), as well as:
    - Real world use of eribulin following treatment with a P13K inhibitor, mostly in people with Hormone Receptor (HR)-positive/HER2-negative metastatic breast cancer.
  • - Preclinical data exploring a liposomal formulation of eribulin, in a Phase 1 expansion cohort for breast cancer, versus eribulin at the same dose, in patient-derived breast cancer xenografts.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Eisai Presents New Data From its Oncology Portfolio and Pipeline at ESMO Congress 2022

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Tuesday, September 6, 2022
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TOKYO, Sept 6, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place virtually and in-person in Paris, France from September 9 to 13.

Key Points: 
  • TOKYO, Sept 6, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place virtually and in-person in Paris, France from September 9 to 13.
  • The study evaluated the combination of lenvatinib plus anti-PD-1 antibody pembrolizumab from Merck & Co., Inc., Rahway, NJ, USA versus lenvatinib monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma.
  • To date, more than 15 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

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Friday, August 5, 2022
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This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.

Key Points: 
  • This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.
  • It is estimated that 287,850 new cases of female breast cancer will be diagnosed in 2022 in the U.S.
  • Of that proportion of breast cancer diagnoses, about 60% of patients previously classified as having HER2-negative subtype can now be considered as HER2-low.
  • The results showed improvement in both progression-free survival and overall survival in people with unresectable or metastatic HER2-low breast cancer.

DGAP-News: iOmx Therapeutics Appoints Dr. Murray Yule as CMO to Lead Clinical Development

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Thursday, February 3, 2022
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Martinsried / Munich, Germany, 03 February, 2022 - iOmx Therapeutics AG (iOmx), a biopharmaceutical company developing cancer therapeutics based on next-generation immune checkpoint targets, today announced the appointment of Dr. Murray Yule, M.D., Ph.D., as Chief Medical Officer (CMO), as of early January, 2022.

Key Points: 
  • Martinsried / Munich, Germany, 03 February, 2022 - iOmx Therapeutics AG (iOmx), a biopharmaceutical company developing cancer therapeutics based on next-generation immune checkpoint targets, today announced the appointment of Dr. Murray Yule, M.D., Ph.D., as Chief Medical Officer (CMO), as of early January, 2022.
  • Murray is a board-certified medical oncologist with extensive experience in leading clinical development programs.
  • "I am delighted to join the outstanding team at iOmx at this important juncture and contribute to their successful transformation into a clinical stage organization.
  • Our lead program, IMT-07, is currently proceeding with Clinical Trial Application (CTA)-enabling studies and aims to enter clinical development in late 2022."

Knight Therapeutics Inc. Announces Approval of Halaven® in Colombia

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Thursday, January 6, 2022
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MONTREAL, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) (Knight or the Company) announced today that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven (eribulin) injection.

Key Points: 
  • MONTREAL, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) (Knight or the Company) announced today that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven (eribulin) injection.
  • Halaven (eribulin) injection has shown to significantly improve overall survival in patients with advanced or metastatic breast cancer after anthracycline and taxane treatment.
  • Were pleased to announce the approval of Halaven (eribulin) injection in Colombia as it provides a new treatment option for metastatic breast cancer and liposarcoma, said Samira Sakhia, President & Chief Executive Officer.
  • Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2020 as filed on www.sedar.com .