The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...
ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being ... patients with HER2-low and HER2-ultralow expression. 2 The FDA approval of ...
As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be ...