Cambridge, MA — Shorla Oncology has announced U.S. Food and Drug Administration (FDA) approval of TEPYLUTE® 100mg, the first and only ready-to-dilute multi-dose vial of thiotepa available for the treatment of breast and ovarian cancer. The approval marks Shorla’s fourth product launch in the U.S. market and includes the commercial rollout of both 15mg and 100mg vials.
Unlike older formulations that require reconstitution, TEPYLUTE arrives as a liquid, simplifying preparation and potentially reducing dosing errors. Once opened, the 100mg/10mL multi-dose vial is stable for up to 14 days when stored properly, offering oncology providers greater flexibility and efficiency in treatment planning.
“We are pleased to offer another viable treatment option for patients with breast and ovarian cancer,” said Sharon Cunningham, CEO and Co-Founder of Shorla Oncology. “This approval enhances convenience for providers and supports timely patient care.”
Thiotepa, a well-established chemotherapy drug that has been in use since the 1950s, has traditionally been available only in freeze-dried powder form requiring time-consuming reconstitution. Shorla’s liquid formulation of TEPYLUTE aims to eliminate this step, streamlining clinical workflow and improving dosing precision.
“This is a huge win for providers,” said Orlaith Ryan, Chief Technical Officer and Co-Founder of Shorla. “With TEPYLUTE, clinicians can avoid complex preparation processes and deliver care more efficiently.”
Chief Commercial Officer Rayna Herman added that the product’s stability and ready-to-use nature support more responsive care models. “TEPYLUTE allows for just-in-time preparation, offering consistent dosing accuracy and making a real difference in patient treatment delivery,” she said.
The approval and launch come amid rising cancer incidence rates. The American Cancer Society projects that in 2025, more than 300,000 women in the U.S. will be diagnosed with breast cancer and nearly 21,000 will be diagnosed with ovarian cancer.
Shorla Oncology, based in the U.S. and Ireland, focuses on developing and commercializing oncology treatments that improve patient and provider experiences with established therapies.
