The Swiss pharmaceutical company said the FDA backed a label expansion for the Pathway HER2 (4B5) test to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who could be ...
The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...
As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast ...
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 ...
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 ...
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
Several new treatment options for patients with breast cancer have emerged over the last few years, including more oral ...
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 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.
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FDA Expands Label of AZN's Enhertu for New Breast Cancer IndicationAstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...
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