SH-105 Gains FDA Approval for Breast, Ovarian Cancers

The FDA approved SH-105, an injectable drug for patients with breast and ovarian cancers. | Image Credit: BHM - stock.adobe.com

Shorla Oncology received an FDA approval for SH-105 (Tepylute) for patients with breast and ovarian cancers.¹ The New Drug Application (NDA) for SH-105 highlighted its prediluted injectable format, simplifying administration and promoting accurate dosage.

Originally established in the 1950s, SH-105 was utilized as a freeze-dried powder, thiotepa (Tepadina), and experienced supply chain shortages.² With the liquid formula, SH-105 eliminates the need for powder to be reconstituted. Overall, the liquid formula has improved efficacy and reduces risks associated with the complexity of preparation.

Prior to SH-105’s approval, Shorla Oncology held a preinvestigational new drug application (IND) meeting with the FDA in 2019.³ The meeting concluded successfully with developers agreeing SH-105 has various benefits for patients with breast and ovarian cancers.

In contrast, the prescribing recommendations for thiotepa state that the medication is injected after a provider reconstitutes it; the dosage is either 15 mg or 100 mg of the lyophilized white powder in a single-dose vial.⁴

Orlaith Ryan, chief technical officer and cofounder of Shorla Oncology, said, “The approval of Tepylute represents an important milestone for Shorla as our first in-house developed NDA.”¹

This approval marks Shorla’s third US market cancer drug application. The company's momentum is bolstered by its recent $35 million Series B funding, which leaders hope will accelerate their oncology portfolio development.²

Sharon Cunningham, CEO of Shorla Oncology, stated “The investment will underpin the advancement and commercialization of our oncology drugs ensuring we continue to deliver on our mission of bringing promising treatments to patients around the globe.”⁵

In addition to pursuing injectable medications, Shorla Oncology is pioneering a patient-friendly approach with SH-201, the first palatable oral liquid treatment for specific leukemias and cancers.¹ The FDA accepted the NDA for SH-201 in April 2024, with a potential approval decision expected by November.

“Among Tepylute’s many benefits, it removes the necessity to reconstitute which can introduce additional risks of drug preparation errors,” emphasized Rayna Herman, chief commercial officer at Shorla.¹ “We look forward to providing an update on our launch plans for tepylute 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://www.businesswire.com/news/home/20240628930127/en/Shorla-Oncology-Announces-FDA-Approval-for-TEPYLUTE-A-Novel-Formulation-to-Treat-Breast-and-Ovarian-Cancer

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 June 28, 2024. https://www.businesswire.com/news/home/20240109305168/en/Shorla-Oncology-Announces-FDA-Filing-Acceptance-of-New-Drug-Application-for-Novel-Formulation-to-Treat-Breast-and-Ovarian-Cancer

3. SH-105 successful FDA pre-IND meeting. Shorla Oncology. June 14, 2019. Accessed June 28, 2024. https://shorlaoncology.com/sh105-successful-fda-pre-ind-meeting/

4. Tepadina. Prescribing information. Amneal Pharmaceuticals; 2020. Accessed June 28, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208264Orig1s003Corrected_lbl.pdf

5. Shorla Oncology secures $35M series B funding round to advance its oncology product portfolio. News release. Shorla Oncology. October 4, 2023. Accessed June 28, 2024. https://www.businesswire.com/news/home/20231004152524/en/Shorla-Oncology-Secures-35M-Series-B-Funding-Round-to-Advance-its-Oncology-Product-Portfolio