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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 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.
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 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.
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.
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
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,
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer
The FDA's nod is based on late-stage data, which show AZN's Datroway cuts the risk of disease progression/death by 37% vs chemotherapy in certain breast cancer patients.
FDA Approves Datroway for Advanced HR+, HER2- Breast Cancer
The FDA has approved Datroway (datopotamab deruxtecan) to treat adults with unresectable or metastatic, HR+, HER2- breast cancer who have received prior endocrine therapy and chemotherapy.
STAT
3d
A next-generation form of chemotherapy wins FDA approval
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BioSpace
3d
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.
12h
AstraZeneca To Pump $570 Million Into Canada, Driving Expansion, Job Growth
AstraZeneca invests $570 million in Canada, expands facilities, and boosts R&D efforts, aiming to deliver 20 new medicines ...
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