pharmaphorum3d
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 ...
Yahoo Finance7d
FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from the US Food and Drug Administration (FDA) for an expanded indication of ...
Benzinga.com8d
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients
Enhertu reduced the risk of disease progression or death by 36%, with a median PFS of 13.2 months versus 8.1 months for chemotherapy. The trial showed an ORR of 62.6% for Enhertu compared to 34.4% ...
Business Insider9d
Enhertu approved in the US as HER2-directed therapy
AstraZeneca (AZN) and Daiichi Sankyo’s ENHERTU has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor, HR,-positive, HER2-low or HER2 ...
Yahoo Finance8d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...
MedPage Today9d
FDA Expands Enhertu Approval to HER2-Ultralow Breast Cancer
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...