FDA, AstraZeneca and breast cancer

AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer
The clearance of Datroway comes months after the companies narrowed approval plans in lung cancer and opens up a market opportunity analysts estimate to be worth about $500 million annually.
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer
AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), in patients with a certain type of breast cancer. The drug, developed in partnership with Japan-based Daiichi Sankyo,
FDA Approves AstraZeneca's Datroway For Pretreated Breast Cancer Patients
On Friday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s (NASDAQ:AZN) Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with unresectable or metastatic hormone receptor (HR)-positive,
FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer
Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a significant reduction in the risk of disease progression or death in patients with previously treated,
AstraZeneca, Daiichi Sankyo win first U.S. approval for key cancer drug
A drug from AstraZeneca and Daiichi Sankyo won authorization for a form of breast cancer, the first U.S. approval for the closely watched treatment.
After Tough 2024, AstraZeneca/Daiichi Sankyo Push Enters Key Period
Even before the FDA's recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024.
FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or metastatic hormone receptor HR+, HER2- breast cancer in adult patients who have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease, according to a news release.
AstraZeneca And Daiichi Sankyo's Datroway Gets US Approval For Metastatic HR+ Breast Cancer
British drug maker AstraZeneca Plc (AZN.L, AZN) and Daiichi Sankyo (DSKYF.PK) announced Monday that their Datroway (datopotamab
AstraZeneca/Daiichi Sankyo’s Datroway granted FDA approval in breast cancer
AstraZeneca (AZ) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) has been approved by the US Food and Drug Administration (FDA) to treat a subset of breast cancer patients.
AstraZeneca’s Strategic Positioning and Datroway Approval Drive Buy Rating Amidst Evolving Breast Cancer Treatment Landscape
Analyst Andrew Berens of Leerink Partners maintained a Buy rating on AstraZeneca (AZN – Research Report), retaining the price target of ...
BioSpace1d
AstraZeneca, Daiichi Sankyo’s ADC Wins First Approval Despite Mixed Data
DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
STAT1d
A next-generation form of chemotherapy wins FDA approval
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.