The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...

Given the evolving role of trastuzumab deruxtecan (Enhertu) in the treatment of breast cancer, especially those who are HER2 ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

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: ...

For symptomatic ILD/pneumonitis (Grade 2 or greater ... diverse breast cancer tumor environment. With fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are ...

The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine (T-DM1) reduced the long-term risk of death or invasive disease by 46% and ...

FDA approval of PATHWAY HER2 (4B5) test expands diagnostic capabilities for HER2-ultralow metastatic breast cancer, enabling targeted treatment with trastuzumab deruxtecan. HER2-ultralow ...

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...