Ready-to-Dilute Thiotepa Approved for Breast and Ovarian Adenocarcinomas

The approval covers single- and multi-dose vials of thiopeta.

The FDA has approved a ready-to-dilute, multi-dose formulation of thiotepa (Tepylute) for use in breast and ovarian adenocarcinomas, according to a news release from Shorla Oncology, the US-Ireland pharmaceutical company that developed the product.

The vial may reduce preparation time and will not require reconstitution, unlike the standard-of-care freeze-dried powder formulation, which has been produced as such since the 1950s. According to Shorla Oncology’s website, this formulation may reduce manual compounding time by 30% compared with lyophilized thiotepa.²

“This is a huge win for providers because [ready-to-dilute thiotepa] avoids the need for complicated and time-consuming reconstitution,” said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, in the news release.

This approval covers 15 mg and 100 mg/10mL vials of thiotepa for treatment and is the first approved multi-dose formulation of thiotepa. According to the release, the vial will be stable for 14 days when properly stored.

Safety Profile

Those with severe hypersensitivity to thiotepa are not advised to receive this formulation of thiotepa, nor are those with live or attenuated vaccines. The drug may cause severe myelosuppression and may be carcinogenic in humans.^2,3

Additional adverse events associated with ready-to-dilute thiotepa include infection, hypersensitivity, cutaneous toxicity, hepatic veno-occlusive disease, and central nervous system toxicity.³ The formulation can cause fetal harm if administered to a patient who is pregnant.

If a patient’s bone marrow has previously been compromised by irradiation or chemotherapy, or if the patient is recovering from chemotherapy, they may have an increased risk of severe myelosuppression. In the event that a patient develops infections, bleeding, or symptomatic anemia, supportive care should be provided.

The ready-to-dilute formulation of thiopeta may reduce preparation time by up to 30%.

“We are excited to bring [ready-to-dilute thiotepa] to the US market,” said Rayna Herman, chief commercial officer of Shorla Oncology, in the release. “It provides consistent dosing accuracy and allows for ‘just-in-time’ preparation, which benefits everyone, especially patients.”

The ready-to-dilute injection is available as a 15 mg/1.5 mL-strength single-dose vial containing 15 mg of thiotepa and 1.7 g of polyethylene glycol 400, and as a 100 mg/10 mL-strength multiple-dose vial containing 100 mg of thiotepa and 11.3 g of polyethylene glycol 400.

The approved thiotepa injection is considered a hazardous drug and should be handled and disposed of as such.

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 TEPYLUTE 15mg and 100mg Vials in the U.S. 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 (thiotepa) injection. Shorla Oncology. Accessed April 29, 2025. https://shorlaoncology.com/product/tepylute/
3. Tepylute package insert. Updated February, 2025. Accessed April 29, 2025. https://shorlaoncology.com/tepylute-pi/