Dr. Debu Tripathy discussed the importance of understanding the distinctions between HER2-low and HER2-ultralow breast cancer ...

The FDA makes furthering moves in SCLC, ovarian, and breast cancers, and the value of remote clinical pharmacists is explored in community oncology.

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

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic breast ...

The company’s PATHWAY HER2 antibody test—used to help screen patients for treatment with Enhertu (trastuzumab deruxtecan-nxki), the antibody-drug conjugate jointly developed by Daiichi Sankyo ...

The approval was granted through Priority Review and Breakthrough Therapy Designation pathways, with HR and ... Breast06 phase 3 trial showed that Enhertu demonstrated superiority compared with ...

The approval was granted through Priority Review and Breakthrough Therapy Designation pathways, with HR and HER status determined by an FDA-approved test. Additionally, patients had to have had ...

The PATHWAY HER2 (4B5) test was used as part of the DESTINY-Breast06 trial, which showed a median progression-free survival of 13.2 months with ENHERTU compared to 8.1 months with the standard of care ...