For patients with high-risk, early-stage estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 ...
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
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A New 'Missile' Drug Is Approved To Treat the Most Common Breast Cancer TypeFact checked by Nick Blackmer The Food and Drug Administration (FDA) recently approved a new targeted chemotherapy drug for ...
In this episode of Targeted Talks, Aditya Bardia, MD, MPH, FASCO, discusses the recent FDA approval of datopotamab deruxtecan ...
Alphamab Oncology (Stock Code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for ...
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: ...
The researchers found that imlunestrant prolonged progression-free survival (PFS) when compared to standard care in patients with ESR1 mutations, but there was no PFS benefit observed in the overall ...
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