FDA Approves Novel Formulation for Breast and Ovarian Cancers

A ready-to-dilute formula of SH-105 has been approved by the FDA to treat breast and ovarian cancers.

The FDA has approved SH-105 (Tepylute), a ready-to-dilute formulation and injectable product to help treat breast and ovarian cancers, according to a press release from the developers, Shorla Oncology.¹

SH-105 is a liquid form of thiotepa, a current standard-of-care oncology drug. In this new formulation, the agent may eliminate the need for complex and time-consuming reconstitution. Additionally, accurate dosing can help with administering on time.

‘’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 the press release.¹ "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."

The drug developer is currently working on additional products to treat various types of cancer. SH-201 will be an oral liquid treatment for certain types of leukemia. A new drug application was accepted by the FDA in April 2024 for SH-201, with a Prescription Drug User Fee Act Date of November 30, 2024.²

"Among [SH-105’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.¹ "We look forward to providing an update on our launch plans for [SH-105] in the near future."

References

1. Shorla Oncology announces FDA approval for TEPYLUTE, a novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. June 28, 2024. Accessed June 28, 2024. https://shorturl.at/EBFEl
2. Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukemia and other cancers. News release. Shorla Oncology. April 8, 2024. Accessed April 8, 2024. https://shorturl.at/1hv6R