AstraZeneca, ADC and FDA

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.
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,
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,
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.
FDA Approves New ADC for HR+, HER2- Breast Cancer
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
DATROWAY® Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer
DATROWAY Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer
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.
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Daiichi Sankyo buys solid tumour ADC from Glycotope for $132.5m
Daiichi Sankyo has finalised the acquisition of intellectual property rights for gatipotuzumab, an anti-tumour-associated ...
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After Tough 2024, AstraZeneca/Daiichi Sankyo Push Enters Key Period
Analysts predict sales of Dato-DXd could hit $5.9 billion in 2030, but the antibody-drug conjugate faced a series of setbacks ...
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AZ, Daiichi get FDA nod for Dato-DXd in breast cancer
The US regulator has cleared TROP2-directed ADC datopotamab deruxtecan (Dato-DXd) under the Datroway trade name as a ...
Daiichi Sankyo Acquires Intellectual Property Rights for Anti-TA-MUC1 Antibody in DS-3939 from Glycotope GmbH
Daiichi Sankyo Company, Ltd (TSE: 4568) announced today that it will pay Glycotope $132.5 million to acquire intellectual ...