AstraZeneca (AZ) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been approved by the European Commission (EC) for use in certain cases of pre-treated breast cancer.
The drug has been authorised for use in adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by results from the phase 3 TROPION-Breast01 trial, in which intravenous Datroway reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy.
Median progression-free survival was 6.9 months in patients randomised to receive Datroway compared to 4.9 months in those treated with chemotherapy.
Additionally, a confirmed objective response rate of 36% was seen in the Datroway cohort versus 23% in the chemotherapy arm, and the median duration of response was 6.7 months for Datroway and 5.7 months for chemotherapy.
Approximately 557,000 people are diagnosed with breast cancer every year in Europe, with HR-positive, HER2-negative breast cancer accounting for around 70% of cases.
Endocrine therapies are typically given in the early lines of treatment for those with HR-positive metastatic disease. However, further efficacy 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 is an antibody drug conjugate, 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.
The drug, which is specifically designed to target TROP2-expressing tumour cells, was discovered by Daiichi Sankyo and is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Dave Fredrickson, executive vice president, oncology haematology business unit, AZ, said: “Though the HR positive breast cancer treatment landscape has evolved in the last several years, disease progression on front-line therapies remains a common and complex challenge for patients with metastatic disease.
“With [this] approval of Datroway, patients in the EU with HR-positive, HER2-negative breast cancer now have a new and needed alternative to conventional chemotherapy.”