AstraZeneca (AZ) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) has been approved by the US Food and Drug Administration (FDA) to treat a subset of breast cancer patients.
The TROP2-targeting antibody drug conjugate (ADC) has been authorised for use in adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy.
The FDA’s decision was based on positive results from the late-stage TROPION-Breast01 trial, in which intravenous Datroway reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy.
The safety profile of Datroway was also shown to be consistent with the known profile of the drug, with no new safety concerns identified.
More than 300,000 people are diagnosed with breast cancer in the US every year, and HR-positive, HER2-negative breast cancer accounts for approximately 70% of cases.
Endocrine therapies, which work by either lowering the amount of hormones in the body or blocking them from getting to breast cancer cells, are widely given in the early lines of treatment for those with HR-positive metastatic disease.
However, further efficacy from endocrine therapy is often limited following initial treatment, and the current standard of care at this point is chemotherapy, which is associated with poor response rates and outcomes.
Datroway belongs to a relatively new class of cancer drugs that combine the selectivity of antibodies with the potent cell-killing power of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones.
Additional regulatory submissions for Datroway in breast cancer are under review in the EU, China and other markets, the companies said.
Global principal investigator for TROPION-Breast01 Aditya Bardia, UCLA Health Jonsson Comprehensive Cancer Center, said: “Despite considerable progress in the HR-positive, HER2-negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy.
“The approval of [Datroway], a novel TROP2-directed ADC, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy.”