The US Food and Drug Administration (FDA) has approved speciality pharmaceutical company Shorla Oncology’s new drug application (NDA) for TEPYLUTE, a new formulation to treat breast and ovarian cancer.
TEPYLUTE is the third drug in the company’s portfolio to obtain FDA approval, with several other cancer drugs awaiting approval for the US market.
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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.
This new liquid formulation of thiotepa, a standard oncology product, removes the requirement for complex reconstitution and supports “just in time” preparation, enhancing consistency in dosing.
Shorla Oncology chief commercial officer Rayna Herman stated: “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.”
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By GlobalDataShorla Oncology is also advancing its portfolio with SH-201, a palatable oral liquid treatment for certain types of leukaemia and other cancers.
The FDA has accepted SH-201 for NDA review in April 2024, with an approval decision anticipated by 30 November.
The company’s pipeline focuses on oncology therapies targeting orphan and paediatric cancers, aiming to address unmet needs, drug shortages and inadequate applications for the intended populations.
Shorla is offering two assets, including Nelarabine, for the treatment of T-cell leukaemia, and JYLAMVO for acute lymphoblastic leukaemia, among other indications.
Shorla Oncology CEO and co-founder Sharon Cunningham said: ‘’This approval fulfils an unmet need by addressing the shortcomings and handling complexities of the current lyophilised powder formulation.
“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.”
