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Pharmaceutical Technology on MSNFDA expands Enhertu approval to include HER2-ultralow breast cancer patientsEnhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In 2022, the drug became the first therapy approved for H ...
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer.
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval for their ... The U.S. regulator has cleared Enhertu as the first HER2-directed treatment for patients with HER2-low or ...
By analyzing ERBB2 mRNA expression data, researchers identified a group of HER2-negative patients with poor outcomes and potential markers of treatment resistance.
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
AZ and Daiichi Sankyo already claimed FDA approval for the HER2-low indication in the US last summer, adding to Enhertu's lengthening list of indications, which also includes second- and third ...
(AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive ...
Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY ...
Daiichi Sankyo promoted Hiroyuki Okuzawa to CEO, and he will take over from Sunao Manabe on April 1. Okuzawa is currently ...
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