We think Roche's drug portfolio and industry-leading diagnostics conspire to create maintainable competitive advantages. As the market leader in both biotech and diagnostics, this Swiss healthcare ...
The firm will share new overall survival data from the INAVO120 trial with regulators to support the breast cancer drug's approval.
T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early breast cancer.
Patients whose metastatic colorectal cancer has progressed following chemotherapy and who lack mutations in the RAS and BRAF ...
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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 addition of trastuzumab and pertuzumab to chemotherapy was associated with increased toxicity in patients with ...
The agency approved the drug based on data from the DESTINY-Breast06 trial, which included patients who had tumors with very low HER2 expression.
New approval brings the medicine to an earlier treatment setting and a broader patient population.
The FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...