FDA approves ‘novel’ formulation to treat breast and ovarian cancer

The US Food and Drug Administration (FDA) has approved Shorla Oncology’s new drug application for TEPYLUTE, a new formulation to treat breast and ovarian cancer.

The American Cancer Society estimates that more than 300,000 women will be diagnosed with breast cancer in the US in 2024. About 19,680 US women will be diagnosed with ovarian cancer.

TEPYLUTE is the third drug in the Shorla portfolio to obtain FDA approval, with several other cancer drugs awaiting approval for the US market.

Previously known as SH-105, the asset is a ready-to-dilute, injectable product that simplifies preparation and ensures dosing accuracy for breast and ovarian cancer treatments.

According to Shorla, this new liquid formulation of thiotepa, a standard oncology product, removes the requirement for complex reconstitution and supports “just in time” preparation, providing “consistent” dosing accuracy.

“This approval fulfils an unmet need by addressing the shortcomings and handling complexities of the current lyophilised powder formulation,” said Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology.

“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.”

Rayna Herman, chief commercial officer of Shorla Oncology, said: “Among TEPYLUTE’s many benefits, it removes the necessity to reconstitute which can introduce additional risks of drug preparation errors. We look forward to providing an update on our launch plans for TEPYLUTE in the near future.”

Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, added: “The approval of TEPYLUTE represents an important milestone for Shorla as our first in-house developed NDA.”

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