Abstract PS1-13-15: A new FDA approved docetaxel + albumin formulation for breast cancer treatment

Abstract Docetaxel was first approved as an anti-neoplastic agent in 1996 and is still used extensively for breast cancer treatment. Currently, available formulations for docetaxel use synthetic excipients, such as polysorbate 80, which are associated with hypersensitivity reactions. Here we describe a novel, polysorbate 80 free, docetaxel formulation with human albumin, BEIZRAY (BH009), which is FDA approved based on demonstrated bioequivalence to generic docetaxel. The bioequivalence study, NCT04889599, was a multicenter, randomized, open-label, 2-way crossover study, comparing the pharmacokinetics and safety of BH009 and docetaxel (Winthrop docetaxel injection, an authorized generic of Taxotere). 46 patients were randomized in the study and received single-dose of 75 mg/m2 BH009 or Taxotere IV over 60 min, with a 21-day washout between doses. The study demonstrated bioequivalence between BH009 and Taxotere based on PK parameters Cmax, AUC0-t and AUC 0-∞. Furthermore, BH009 demonstrated favorable grade 3/4 AE profiles than Taxotere. In conclusion, breast cancer patients now have a new docetaxel + human albumin formulation that is FDA approved via 505(b)(2) pathway, which may overcome the challenges associated with polysorbate 80 related hypersensitivity reactions. Citation Format: H. Biswas, D. Desai, Q. Sun. A new FDA approved docetaxel + albumin formulation for breast cancer treatment [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-13-15.