US FDA approves Daiichi, AstraZeneca drug for treatment of solid tumors
Reuters
Published Apr 05, 2024 05:38PM ET
(Reuters) - The U.S. Food and Drug Administration on Friday gave accelerated approval for the expanded use of Daiichi Sankyo and AstraZeneca (NASDAQ:AZN)'s drug to treat patients with a type of solid tumor.
The drug, sold under the brand name Enhertu, originally won U.S. approval in late 2019 as a third-line treatment for HER-2-positive breast cancer patients, and the fresh approval opens the treatment across multiple HER2-expressing solid tumors.
HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers, according to AstraZeneca.
The drug showed clinically meaningful survival benefits in previously treated patients in three mid-stage trials.
AstraZeneca secured partial rights to the Daiichi Sankyo compound in 2019 in a deal worth up to $6.9 billion. In 2023, the drug generated sales of $1.28 billion as a treatment for breast cancer, gastric cancer and lung cancer.
Enhertu belongs to a class of therapies called antibody-drug conjugates (ADC) and comprises a monoclonal antibody - in this case trastuzumab (also known as Herceptin) - chemically linked to a cell-killing chemotherapy drug.
Get The News You Want
Written By: Reuters
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.