(Reuters) – The U.S. Food and Drug Administration on Friday gave accelerated approval for the expanded use of Daiichi Sankyo and AstraZeneca’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.
(Reporting by Christy Santhosh; Editing by Vijay Kishore)
