FDA Approves Ready-to-Dilute Tepylute for Breast and Ovarian cancer

The U.S. Food and Drug Administration (FDA) has approved treatment with 100 milligrams of Tepylute for breast and ovarian cancers, according to a press release from Shorla Oncology.

“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, said in the press release. “Once opened, our 100-milligram 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 version of thiotepa, a standard drug used to treat breast and ovarian cancer. This new formulation may save time and reduce preparation errors by eliminating reconstitution and offering more scheduling flexibility. Since the 1950s, thiotepa has been manufactured as a freeze-dried powder.

The approval includes 100- and 15-milligrams vials.

“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, said in the press release.

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