Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has granted approval for the 100 mg/10 mL multi-dose vial of Tepylute, a ready-to-dilute formulation of thiotepa to treat breast and ovarian cancers, that eliminates the need for reconstitution and may reduce preparation time and errors, thus offering more scheduling flexibility for patients.
“We are pleased to offer another viable treatment option for patients with breast and ovarian cancer,” said Sharon Cunningham, the CEO and co-founder of Shorla Oncology. “Once opened, our 100-mg vial of Tepylute is stable for 14 days when properly stored, giving providers the flexibility they need when preparing and administering this very important treatment.”
Tepylute is a ready-to-dilute formulation of the well-established, standard-of-care oncology drug thiotepa, that has been manufactured as freeze-dried powder since the 1950s.
“This is a huge win for providers because Tepylute avoids the need for complicated and time-consuming reconstitution,” said Orlaith Ryan, the chief technical officer and co-founder of Shorla Oncology.
“We are excited to bring Tepylute to the U.S. market. It provides consistent dosing accuracy and allows for ‘just in time’ preparation, which benefits everyone, especially patients,” said Rayna Herman, the chief commercial officer of Shorla Oncology.
Based on a press release from Shorla Oncology.