US-Ireland speciality pharmaceutical firm Shorla Oncology has received the US Food and Drug Administration (FDA) approval for Tepylute (SH-105) to treat breast and ovarian cancer.
Tepylute is a ready-to-dilute formulation and injectable product. It represents a liquid formulation of an oncology medication thiotepa.
The formulation removes the requirement for intricate and time-intensive reconstitution processes. It ensures precise dosing and facilitates prompt preparation as needed.
In January last year, the pharmaceutical company announced that the FDA accepted the filing of the New Drug Application (NDA) for the new formulation.
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.”
SH-105 marks Shorla’s third FDA-approved drug. Currently, the company is pursuing approval for multiple oncology treatments in the US.
The commercial stage firm presently markets two products and maintains a strong pipeline, including SH-201.
It is an initial palatable oral liquid treatment designed for specific types of leukaemia and other cancer indications.
In April, the company disclosed that the FDA had accepted SH-201 for NDA review, with an anticipated decision date set for 30 November 2024.
Shorla Oncology maintains an advanced pipeline of oncology medications tailored for orphan and paediatric cancers.
The company concentrates on indications where current treatments are scarce, inadequate, or insufficient for the target demographic.
Its expanding portfolio provides accessible, cost-effective, and life-saving therapies to improve patient care.
Currently, the American Irish firm markets two products, including Nelarabine for T-cell Leukaemia treatment and Jylamvo for acute lymphoblastic leukaemia and other indications.
Shorla Oncology raised $35m in Series B funding in October 2023 to advance its oncology product portfolio.
