Shorla Oncology Gets FDA Nod for TEPYLUTE to Treat Breast and Ovarian Cancer

CAMBRIDGE, Mass.-- Shorla Oncology, a U.S.-Ireland specialty pharmaceutical firm, has announced the FDA approval of their New Drug Application (NDA) for TEPYLUTE. This drug is a ready-to-dilute version of thiotepa, designed to treat breast and ovarian cancers. Its formulation simplifies preparation and ensures accurate dosing, addressing significant challenges associated with the current lyophilized powder form.

Sharon Cunningham, CEO and Co-Founder of Shorla Oncology, emphasized that this approval addresses an unmet need by simplifying the preparation process and minimizing medical personnel’s exposure to hazardous drugs. Cunningham highlighted that TEPYLUTE makes it easier for oncology clinics and hospitals to manage treatments, thus improving overall patient care.

TEPYLUTE, previously known as SH-105, is Shorla’s third FDA-approved drug, marking a significant achievement for the company. Orlaith Ryan, Shorla’s Chief Technical Officer and Co-Founder, noted that this approval is particularly notable as it is the company’s first internally developed NDA. Ryan expressed optimism about the company's future endeavors, particularly in the U.S. market.

The new liquid formulation of thiotepa offered by TEPYLUTE removes the need for complex reconstitution, which is often time-consuming and poses a risk of preparation errors. Rayna Herman, Shorla’s Chief Commercial Officer, highlighted that this ready-to-dilute formulation reduces the risks associated with drug preparation mistakes. Herman also mentioned that further details on the launch strategy for TEPYLUTE would be shared soon.

Breast and ovarian cancers are significant health concerns in the United States. The American Cancer Society estimates that over 300,000 women will be diagnosed with breast cancer in 2024, and approximately 19,680 women will be diagnosed with ovarian cancer. Shorla Oncology aims to contribute to the fight against these prevalent cancers through innovative treatments like TEPYLUTE.

Shorla Oncology markets two other products and has a robust pipeline of new treatments under development. Among these is SH-201, the first palatable oral liquid treatment for certain types of leukemia and other cancers. In April, the FDA accepted SH-201 for NDA review, with a decision expected by November 30, 2024.

Founded by Sharon Cunningham and Orlaith Ryan, Shorla Oncology is a privately-held company operating in the U.S. and Ireland. The company focuses on developing oncology drugs for orphan and pediatric cancers, areas where treatment options are limited or inadequate. Shorla's mission is to make accessible, affordable, and life-saving treatments available to patients, thereby significantly improving patient care. The company currently offers two marketed products: Nelarabine for T-cell leukemia and JYLAMVO for acute lymphoblastic leukemia and other conditions.

Shorla’s commitment to addressing unmet medical needs and improving cancer treatment options underlines their significant role in the pharmaceutical industry, particularly in oncology. With the approval of TEPYLUTE, the company is poised to further its impact on cancer care, providing innovative solutions to some of the most challenging aspects of oncology treatment.