Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
The FDA on Friday gave the greenlight to AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate datopotamab deruxtecan, or Dato-DXd—now to carry the brand name Datroway—for the treatment of certain types of breast cancer.
Friday’s decision marks Datroway’s first U.S. approval and opens up its use in adult patients with unresectable or metastatic disease and who are HR-positive and HER2-negative. Datroway can be given to those who have undergone prior lines of chemotherapy and endocrine-based therapy.
Datroway will cost nearly $4,900 per vial, Reuters reported. The treatment will hit U.S. shelves in approximately two weeks, according to Daiichi Sankyo’s announcement of the approval.
In a note to investors on Tuesday morning, analysts at Leerink Partners predicted that with its current indication, Datroway will achieve “modest peak revenues” of approximately $540 million worldwide. “We think that Datroway in HR+ breast cancer will be relegated to the third line and beyond as the HR+ breast cancer treatment paradigm evolves,” the analysts continued.
In this setting, however, Datroway would compete with the partners’ own Enhertu, which is approved for patients with low HER2 expression. In this subpopulation, Datroway would likely be relegated as a fourth- or fifth-line treatment, the Leerink analysts wrote, adding that “we see greater room for Datroway in HR+/HER2 null” patients.
In particular, Leerink sees a greater opportunity for Datroway in triple-negative breast cancer, for which AstraZeneca and Daiichi Sankyo are anticipating a readout in the first half of this year.
Datroway’s approval on Friday was based on data from Phase III TROPION-Breast01 study, which in October 2023 found that the ADC elicited significant improvements in median progression-free survival. Compared with the investigator’s choice of chemotherapy, Datroway cut the risk of death or disease progression by 37% in patients with HR-positive and HER2-negative breast cancer, an efficacy estimate that the pharma partners at the time labeled as “statistically significant and clinically meaningful.”
However, in a follow-up readout posted in September 2024, the companies announced that Datroway failed to significantly improve overall survival in this patient population.
Datroway is an intravenously administered ADC that makes use of an anti-TROP2 antibody attached to a topoisomerase I inhibitor payload. TROP2 is a signaling protein that is commonly highly expressed in several cancers, and by specifically seeking out and binding to this target, Datroway brings its toxic payload close to malignant cells.
For AstraZeneca and Daiichi Sankyo, Datroway is an asset that holds a lot of promise, especially as they try to secure a foothold for the drug in two particularly lucrative cancer niches: breast cancer and lung cancer. According to a report form Evaluate earlier this month, the ADC could be the second-largest drug launch of 2025, with sales potentially hitting $5.9 billion by 2030.
The road has been rough for the asset, however. In addition to failing to improve overall survival in breast cancer, the companies reported in May 2024 that the ADC was similarly unable to boost overall survival in a Phase III trial in non-small cell lung cancer (NSCLC). This late-stage failure forced the partners to pull a regulatory filing for Datroway in non-squamous NSCLC a few months later.
A new Biologics License Application in NSCLC is currently being reviewed by the FDA, with a decision expected in the third quarter of this year.
