FDA Approves Tepylute for Breast and Ovarian Cancer

The Food and Drug Administration (FDA) approved Tepylute (SH-105), a ready-to-dilute form of the cancer drug thiotepa, for patients with breast or ovarian cancer, according to Shorla Oncology, the manufacturer of the drug.

‘’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 a company-issued press release.

Tepylute is a liquid form of thiotepa, which is a drug used to treat breast, ovarian and bladder cancer, according to the Mayo Clinic. To administer thiotepa, clinicians must first mix the drug — which comes in a powdered form — with a solvent or diluting agent so that it can be administered to the patient via injection.

According to the release, Tepylute is easier to administer and “provides consistent dosing accuracy.”

"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 at Shorla Oncology, in the press release.

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