FDA Approves Tepylute to Treat Breast, Ovarian Cancers


The ready-to-dilute formulation of Tepylute for breast and ovarian cancers can help to reduce prep time and provide more accurate dosing.

FDA Approves Tepylute to Treat Breast, Ovarian Cancers

FDA Approves Tepylute to Treat Breast, Ovarian Cancers

The FDA approved the new drug application for Tepylute (formerly SH-105) for the treatment of breast and ovarian cancer.1

In particular, Tepylute is a ready-to-dilute formulation with easy preparation and dosing accuracy for this injectable treatment, according to a press release from Shorla Oncology, the manufacturer of Tepylute.

“This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation, Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology, said in the release. “We have taken a vital oncology drug and made it easier for oncology clinics and hospitals to use, while also reducing medical personnel exposure to a hazardous drug.”

Tepylute is the liquid form of thiotepa (Tepadina). According to the prescribing information for thiotepa, the therapy is typically for injection and comes in a 15 mg or 100 mg lyophilized white powder in a single-dose vial for reconstitution.2 This newly approved liquid form eliminates the need for reconstitution, which can often be a complex and time-consuming process.1 The liquid formulation provides consistent dosing accuracy and timely preparation.

“Among Tepylute’s many benefits, it removes the necessity to reconstitute, which can introduce additional risks of drug preparation errors,” said Rayna Herman, Chief Commercial Officer for Shorla Oncology, in the release.


  1. Shorla Oncology Announces FDA Approval for TEPYLUTE, A Novel Formulation to Treat Breast and Ovarian Cancer. News release. Business Wire. June 28, 2024. Accessed June 28, 2024. https://www.businesswire.com/news/home/20240628930127/en/Shorla-Oncology-Announces-FDA-Approval-for-TEPYLUTE-A-Novel-Formulation-to-Treat-Breast-and-Ovarian-Cancer
  2. Tepadina. Prescribing information. Amneal Pharmaceuticals; 2020. Accessed June 28, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208264Orig1s003Corrected_lbl.pdf
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