FDA Approves Multi-Dose Vial of Thiotepa for Breast and Ovarian Cancer

FDA

The FDA has approved a ready-to-dilute formulation of thiotepa (Tepylute) in a 100-mg/10-mL multi-dose vial for the treatment of patients with breast and ovarian cancer.¹

Thiotepa, which was originally approved by the FDA in 1959, is an alkylating drug indicated for the treatment of adenocarcinoma of the breast or ovary.²

The 100 mg/10 mL could eliminate the need for reconstitution and may reduce preparation time and errors by allowing for increased flexibility with treatment scheduling.¹

“We are pleased to offer another viable treatment option for patients with breast and ovarian cancer,” Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, stated in a news release. "Once opened, our 100-mg vial of [thiotepa] is stable for 14 days when properly stored, giving providers the flexibility they need when preparing and administering this very important treatment."

Along with the approval of the multi-dose vial, Shorla Oncology also announced the commercial launch of 15-mg and 100-mg vials of thiotepa in the United States (US).

"We are excited to bring Tepylute to the US Market. It provides consistent dosing accuracy and allows for 'just-in-time' preparation, which benefits everyone, especially patients," Rayna Herman, chief commercial officer of Shorla Oncology, added in a news release.

In June 2024, the FDA approved a new drug application (NDA) for a ready-to-dilute formulation of Tepylute (formerly SH-105) for the treatment of patients with adenocarcinoma of the breast and ovary.³

As a ready-to-dilute formulation, Tepylute builds upon the original formulation of thiotepa, which was manufactured as a freeze-dried powder.¹

“This is a huge win for providers because Tepylute avoids the need for complicated and time-consuming reconstitution,” Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, stated in a news release.

The most common adverse effects associated with thiotepa included neutropenia, anemia, thrombocytopenia, increased alanine aminotransferase levels, increased aspartate aminotransferase levels, increased bilirubin levels, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria, and rash.²

The prescribing information also carries warnings for myelosuppression and carcinogenicity. Specifically, Tepylute could cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding; it is recommended to monitor patients' hematologic laboratory parameters.

The recommended dose of thiotepa is 0.3 mg/kg to 0.4 mg/kg administered intravenously in 1- to 4-week intervals. The prescribing information recommends that maintenance doses should be adjusted weekly based on pretreatment control blood counts and subsequent blood counts, and maintenance doses should not be given more than once weekly.

Tepylute is contraindicated in patients with severe hypersensitivity to thiotepa and in concomitant use with live or attenuated vaccines.

References

1. Shorla Oncology announces FDA approval of Tepylute 100mg, first and only ready-to-dilute multi-dose vial of thiotepa to treat breast and ovarian cancer and commercial launch of Tempylute 15mg and 100mg Vials in the U.S. News release. Shorla Oncology. April 29, 2025. Accessed April 29, 2025 https://www.businesswire.com/news/home/20250429747360/en/Shorla-Oncology-Announces-FDA-Approval-of-TEPYLUTE-100mg-First-and-Only-Ready-to-Dilute-Multi-Dose-Vial-of-Thiotepa-to-Treat-Breast-and-Ovarian-Cancer-and-Commercial-Launch-of-TEPYLUTE-15mg-and-100mg-Vials-in-the-U.S.
2. Tepylute. Prescribing information. June 2024. Accessed April 29, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216984s000lbl.pdf
3. Shorla Oncology announces FDA approval for Tepylute, a novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. June 28, 2024. Accessed June 28, 2024. https://finance.yahoo.com/news/shorla-oncology-announces-fda-approval-110000280.html