AstraZeneca (AZN) and its partner Daiichi Sankyo announced that the FDA has approved their antibody-drug conjugate, Datroway (datopotamab deruxtecan), for expanded use in breast cancer. The approval, granted on October 3, 2023, allows Datroway to be used in adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy.
The decision was based on data from the phase III TROPION-Breast02 study, which demonstrated statistically significant improvements in overall survival compared to chemotherapy, and resulted in Datroway being added to the NCCN Clinical Practice Guidelines as a Category 1 preferred treatment for this patient population. The study indicated a higher objective response rate and longer duration of response than chemotherapy.
With this latest approval, Datroway is already marketed by AstraZeneca for HR-positive, HER2-negative breast cancer, and is being evaluated globally for various cancers. AstraZeneca’s stock has seen a 1.8% increase this year, while the biotech industry has declined by 0.3%.
5 Stocks Our Experts Predict Could Double In the Next Year
By submitting your email, you'll also get a free pivot & flow membership. A free daily market overview. You can unsubscribe at any time.
