pharmaphorum5d
Enhertu gets first okay for HER2-ultralow breast cancer
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster drug as a second-line treatment for patients with HER2-low and HER2 ...
pharmaphorum2d
Boost to Enhertu's prospects as FDA clears Roche diagnostic
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 ...
FiercePharma5d
Fierce Pharma Asia—Takeda's next CEO; Enhertu's novel FDA nod; East Asian American C-suite execs
Takeda is promoting U.S. chief Julie Kim to be its next CEO. AstraZeneca and Daiichi's Enhertu has won an FDA nod to expand into HER2-ultralow breast cancer. East Asian Americans are ...
The American Journal of Managed Care5d
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
1. Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu. Roche. News release. January 31 ...
Morningstar5d
Roche Gets FDA Approval for Breast Cancer Test
Enhertu was discovered by Daiichi Sankyo and is being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. HER2 is a receptor protein that accelerates the growth of cancer cells.
cancerhealth6d
FDA Approves Enhertu for HER2-Ultralow Metastatic Breast Cancer
On January 27, the Food and Drug Administration (FDA) expanded the approval of Enhertu (fam-trastuzumab deruxtecan) to cover people with hormone-positive, HER2-ultralow advanced breast cancer ...