Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
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 ...
Known as fam-trastuzumab deruxtecan but marketed under the brand name Enhertu, it is meant to treat advanced breast cancer that is HR-positive and HER2-low or ultralow, which has not improved ...
Enhertu (fam-trastuzumab deruxtecan-nxki) can cause side effects that range from mild to serious. More common side effects include hair loss, nausea, and vomiting. If Enhertu side effects become ...
In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA) has ...
Enhertu reduced the risk of disease progression or death by 36%, with a median PFS of 13.2 months versus 8.1 months for chemotherapy. The trial showed an ORR of 62.6% for Enhertu compared to 34.4% ...
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 ...
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 ...
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...