WASHINGTON D.C. – The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Enhertu for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and lack satisfactory alternative options.
Enhertu is an antibody drug conjugate (ADC) specifically engineered to target HER2-positive tumors and is co-developed by AstraZeneca (NASDAQ:) and Daiichi Sankyo.
The approval, announced today, marks the first time a tumor-agnostic HER2-directed therapy has been authorized by the FDA. The decision is based on objective response rate (ORR) and duration of response (DoR) observed in patients across three Phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.
Dr. Funda Meric-Bernstam of The University of Texas MD Anderson Cancer Center highlighted the limited treatment options previously available for patients with metastatic HER2-positive solid tumors and noted the clinically meaningful response rates seen across clinical trials.
Dave Fredrickson from AstraZeneca emphasized the significance of this milestone, stating that Enhertu’s approval underscores the importance of biomarker testing across various tumors to identify patients who may benefit from targeted therapies. Ken Keller of Daiichi Sankyo echoed the sentiment, referencing the clinically meaningful efficacy of Enhertu across different metastatic cancers.
The safety profile of Enhertu was consistent with previous clinical trials, evaluated in 347 patients with unresectable or metastatic HER2-positive solid tumors. The FDA’s accelerated approval is contingent upon the verification and description of clinical benefit in a confirmatory trial.
Furthermore, Enhertu has been included in the NCCN Clinical Practice Guidelines in Oncology as a treatment option for multiple metastatic tumors. The FDA reviewed the US regulatory submission under Project Orbis, allowing for concurrent submission and review among international partners. Enhertu is also under review for the same indication in Australia, Brazil, and Singapore.
Sales of Enhertu in the US are recognized by Daiichi Sankyo, with AstraZeneca reporting its share of gross profit margin from US sales as alliance revenue in its financial statements.
This approval is a significant step for patients with metastatic HER2-positive solid tumors, offering a new therapeutic option where limited treatments were previously available. The information for this article is based on a press release statement.
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