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The American Journal of Managed Care
5 天
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
FierceBiotech
2 天
Roche's Enhertu companion diagnostic secures new FDA approval in HER2-ultralow breast cancer
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
BioPharma Dive
7 天
Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
Pharm Exec
2 天
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow ...
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
Targeted Oncology
2 天
T-DXd Reevaluated in HER2-Low/HER2-Negative Breast Cancer After New Trials
During a Case-Based Roundtable event, Laura Huppert, MD, discussed data and considerations around using T-DXd in breast ...
manilatimes
6 天
Roche receives FDA approval for the first companion diagnostic to identify patients with ...
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...
PharmiWeb
9 天
Enhertu approved in the US as first HER2-directed…
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, ...
oncnursingnews
9 天
FDA Approves T-DXd for Previously Treated HER2-Low and -Ultralow Metastatic Breast Cancer
T-DXd has received FDA approval for the treatment of unresectable or metastatic HR+, HER2-low/-ultralow breast cancer in ...
GlobalData on MSN
8 天
FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from ...
Daily
5 天
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow ...
Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY ...
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