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.
FDA Approves Datroway for Advanced HR+, HER2- Breast Cancer
Findings showed datopotamab deruxtecan reduced the risk of disease progression or death by 37% compared with chemotherapy.
FDA Approves New Treatment for Advanced Breast Cancer
The FDA has approved a new treatment for patients with a common form of breast cancer that has spread to other parts of the body or cannot be surgically removed.
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 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 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,
Datroway, 2nd ADC from AstraZeneca-Daiichi collab, wins first FDA nod in breast cancer
Following a world-first approval in Japan, AstraZeneca and Daiichi Sankyo’s second antibody-drug conjugate has crossed the U.S. regulatory finish line. | AstraZeneca and Daiichi Sankyo’s second antibody-drug conjugate,
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,
FDA approves Datroway for advanced breast cancer
The FDA approved datopotamab deruxtecan-dlnk for treatment of certain patients with advanced breast cancer.The indication applies to use of the agent by adults with hormone receptor-positive, HER2-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
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
Daiichi Sankyo Shares Jump After U.S. FDA Approves Breast Cancer Drug
Daiichi Sankyo shares rose sharply after the U.S. Food and Drug Administration approved its breast cancer drug Datroway. Shares were recently 8.7% higher at 4,437 yen, equivalent to $28.39, on Monday after rising as much as 9.
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 ...
BioSpace2d
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.
STAT2d
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.