FDA Approves Tepylute in Breast and Ovarian Cancer

• Tepylute (SH-105) is a ready-to-dilute formulation of a treatment for breast and ovary adenocarcinoma.
• The original agent was approved in the 1950s and has not been updated since.
• The new formulation provides clinicians and patients with easier access and administration of this agent.

The FDA approved Tepylute, a ready-to-dilute formulation of an existing treatment for breast and ovarian adenocarcinoma.¹

‘’This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation," said Sharon Cunningham, chief executive officer and fo-Founder of Shorla Oncology, in a press release. "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 original non-dilutable agent was originally approved in the 1950s and has not been updated since, according to Shorla Oncology, manufacturer of Tepylute.² The now-approved ready-to-dilute formulation simplifies the drug reconstitution process, which can improve efficiency and reduce preparation risks for clinicians while increasing satisfaction and safety for patients.³

Tepylute is an intravenously administered agent for brain metastasis in patients with breast cancer in its formulation and manufacturing stage. The agent has an estimated commercialization date of Q3 2026.

Shorla Oncology has several other agents in its pipeline. These include SH-110, an oral liquid treatment for glioma. SH-110 is currently in clinical development and has an estimated commercialization date of Q2 2026.

SH-201 is a liquid formulation of a treatment for chronic myeloid leukemia, acute lymphoblastic leukemia (ALL), myelodysplastic syndromes, and gastrointestinal tumors. The FDA accepted the new drug application for SH-201 in April 2024 and set a Prescription Drug User Fee Act target action date of November 30, 2024.⁴

Additionally, Shorla Oncology manufactures Jylamvo, the only approved, oral methotrexate solution for adults, and nelarabine, an injection for the treatment of T-cell ALL and T-cell lymphoblastic lymphoma.²

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://bit.ly/45Rdtko

2. Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. January 9, 2024. Accessed April 25, 2024. http://tinyurl.com/59ksrpnj

3. Pipeline. Shorla Oncology. Accessed April 25, 2024. https://shorlaoncology.com/pipeline/sh-201/

4. 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 25, 2024. https://tinyurl.com/dbrczpjw