The U.S. Food and Drug Administration (FDA) has officially approved a ready-to-dilute multi-dose vial formulation of thiotepa for the treatment of breast and ovarian cancer, offering a more flexible and efficient option for cancer care teams. Developed by Shorla Oncology, the formulation is marketed under the brand name
Tepylute and is the first and only FDA-approved multi-dose thiotepa product available in the U.S. Thiotepa is a well-established alkylating agent that functions by adding alkyl groups to DNA, thereby interfering with the DNA replication process and inducing cancer cell death. It is used in the treatment of various solid tumors and is also a conditioning agent before hematopoietic stem cell transplantation.
The new multi-dose vial is designed for hospital and oncology settings, where drug wastage and preparation time can be significant challenges.
The 100 mg/10 mL vial can be stored for up to 14 days after opening under refrigerated conditions, allowing multiple doses to be drawn safely and conveniently. This advancement improves treatment scheduling, reduces pharmaceutical waste, and enhances patient access to therapy, particularly in high-volume cancer centers.
According to Shorla Oncology, the Tepylute formulation underwent rigorous quality and stability testing to meet regulatory standards. Its approval also reflects the growing shift toward packaging innovations that support sustainability and healthcare system efficiency.
Disclaimer: This article is intended for informational purposes only and does not substitute for professional medical advice, diagnosis or treatment. Patients should consult their healthcare provider for guidance tailored to their individual needs.
