AstraZeneca: first approval for Dato-DXd in the US
(CercleFinance.com) - AstraZeneca announced on Monday that the US FDA has granted marketing authorization for datopotamab deruxtecan (Dato-DXd) for the treatment of hormone receptor-positive (HR+) breast cancer.
The pharmaceutical company points out that the green light from the health agency concerns the treatment of HER2-negative metastatic breast cancer previously treated with endocrine therapy and chemotherapy.
AstraZeneca points out that this is the first approval obtained in the US for this antibody-drug conjugate developed in collaboration with Japan's Daiichi Sankyo.
According to the company, the FDA approval is based on the results of a Phase III study which demonstrated that the product reduced the risk of disease progression or death by 37% compared to chemotherapy.
This antibody-conjugate, which will be marketed under the trade name Datroway, is the eighth of 20 new drugs that AstraZeneca has set itself the goal of launching by 2030.
Following this announcement, AstraZeneca shares gained 0.2% on Monday morning on the London Stock Exchange, bringing to almost 13% their rebound from the low reached last November.
However, the share price has still fallen around 10% over the past six months.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
The pharmaceutical company points out that the green light from the health agency concerns the treatment of HER2-negative metastatic breast cancer previously treated with endocrine therapy and chemotherapy.
AstraZeneca points out that this is the first approval obtained in the US for this antibody-drug conjugate developed in collaboration with Japan's Daiichi Sankyo.
According to the company, the FDA approval is based on the results of a Phase III study which demonstrated that the product reduced the risk of disease progression or death by 37% compared to chemotherapy.
This antibody-conjugate, which will be marketed under the trade name Datroway, is the eighth of 20 new drugs that AstraZeneca has set itself the goal of launching by 2030.
Following this announcement, AstraZeneca shares gained 0.2% on Monday morning on the London Stock Exchange, bringing to almost 13% their rebound from the low reached last November.
However, the share price has still fallen around 10% over the past six months.
Copyright (c) 2025 CercleFinance.com. All rights reserved.