The FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer.
Just days after the FDA approved AstraZeneca and Daiichi Sankyo's Enhertu for a potentially lucrative new use, the regulatory has now cleared a diagnostic test that could help unlock the drug's ...
Enhertu also has a six-month priority review from the US regulator, so a decision on its new use in metastatic, HER2-low breast cancer should be made within six months.
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...
(AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive ...
Trastuzumab deruxtecan (Enhertu; AstraZeneca ... Researchers randomly assigned 436 participants to 5.4 mg/kg trastuzumab deruxtecan every 3 weeks. The other 430 received physician’s choice ...
AstraZeneca received Food and Drug Administration approval for enhertu, its breast cancer treatment developed in partnership with Japanese company Daiichi Sankyo. The Anglo-Swedish pharmaceutical ...
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