⌛ Did you miss ProPicks’ 13% gains in May? Subscribe now & catch June’s top AI-picked stocks early.Unlock Stocks

AstraZeneca's breast cancer treatment BLA gets FDA nod

EditorEmilio Ghigini
Published 04/02/2024, 05:48 AM
© Reuters.
AZN
-

LONDON - AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo have received U.S. Food and Drug Administration (FDA) acceptance for a Biologics License Application (BLA) for their drug datopotamab deruxtecan (Dato-DXd) for patients with a specific type of metastatic breast cancer. This application is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have previously undergone systemic therapy.

The BLA submission is supported by results from the TROPION-Breast01 Phase III trial, which showed a statistically significant improvement in progression-free survival (PFS) for patients treated with datopotamab deruxtecan compared to those who received the investigator's choice of chemotherapy.

While overall survival (OS) data favored datopotamab deruxtecan, the results were not considered mature at the time of the data cut-off. The FDA's decision on the application is expected in the first quarter of 2025.

Datopotamab deruxtecan is an antibody-drug conjugate that targets TROP2, a protein frequently expressed in HR-positive, HER2-negative breast cancers and associated with aggressive tumor growth and poor prognosis. The safety profile of datopotamab deruxtecan in the TROPION-Breast01 trial was consistent with previous studies, with no new safety concerns identified.

This news comes as AstraZeneca and Daiichi Sankyo also have an additional BLA under review in the U.S. for datopotamab deruxtecan as a treatment for advanced nonsquamous non-small cell lung cancer (NSCLC), based on the TROPION-Lung01 Phase III trial. Regulatory submissions for the drug in both lung and breast cancer indications are in progress worldwide.

The acceptance of this BLA by the FDA marks a significant step for AstraZeneca and Daiichi Sankyo in their collaboration to develop and potentially commercialize new cancer treatments. The companies are actively working to provide datopotamab deruxtecan as a new treatment option to patients globally, pending regulatory approvals.

The information in this article is based on a press release statement from AstraZeneca.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Loading next article…
Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.