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 ...
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...
Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY ...
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...
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: ...
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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 ...
Astra is due to pay Daiichi US$175 million in milestones after the US approval, the companies said. Enhertu is cleared in the ...
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...
Enhertu is used in adults to treat the following kinds of cancer in certain situations. People receiving the drug must have received treatment for cancer in the past. Keep reading to learn about ...
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