manilatimes5h
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...
clinicaladvisor.com2d
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...
FiercePharma9h
Fierce Pharma Asia—Takeda's next CEO; Enhertu's novel FDA nod; East Asian American C-suite execs
Takeda is promoting U.S. chief Julie Kim to be its next CEO. AstraZeneca and Daiichi's Enhertu has won an FDA nod to expand into HER2-ultralow breast cancer. | Takeda is promoting U.S. chief Julie Kim ...
Monthly Prescribing Reference3d
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA) has ...
FiercePharma3d
AZ, Daiichi's Enhertu nabs 7th FDA nod, including in 'HER2-ultralow' use, in breast cancer first
The U.S. regulator has cleared Enhertu as the first HER2-directed treatment for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more ...
Cure Today3d
FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer
Enhertu is approved for HR-positive, HER2-low or -ultralow metastatic breast cancer after endocrine therapy progression, based on DESTINY-Breast06 trial results. Enhertu showed a 36% reduction in ...
Yahoo Finance3d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...
pharmaphorum22h
Enhertu gets first okay for HER2-ultralow breast cancer
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster drug as a second-line treatment for patients with HER2-low and HER2 ...
Benzinga.com3d
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients
Enhertu reduced the risk of disease progression or death by 36%, with a median PFS of 13.2 months versus 8.1 months for chemotherapy. The trial showed an ORR of 62.6% for Enhertu compared to 34.4% ...
PharmiWeb3d
Enhertu approved in the US as first HER2-directed…
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year Approval brings ...
Business Insider4d
Enhertu approved in the US as HER2-directed therapy
AstraZeneca (AZN) and Daiichi Sankyo’s ENHERTU has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor, HR,-positive, HER2-low or HER2 ...
London South East3d
Enhertu approved in US for breast cancer post ET
Enhertu approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies ...