Dr. Debu Tripathy breaks down the FDA approval of Enhertu in unresectable or metastatic HR-positive, HER2-low or -ultralow ...
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: ...
AstraZeneca and Daiichi Sankyo's HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) already has ...
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 ...
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan ... with HR and HER status determined by an FDA-approved test. Additionally, patients had to have had disease ...
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from the US Food and Drug Administration (FDA) for an expanded indication of ...
Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of ...
The FDA makes furthering moves in SCLC, ovarian, and breast cancers, and the value of remote clinical pharmacists is explored in community oncology.
How low could Enhertu go? The FDA’s answer came on Tuesday. In addition to becoming the first treatment for those whose tumors show a lower level of the HER2 protein biomarker, the nod moves ...
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