SH-105 Gains FDA Approval for Breast, Ovarian Cancers
The FDA approved SH-105 (Tepylute) prediluted injectable treatment for breast and ovarian cancers. This innovative formulation eliminates the need for complex powder reconstitution, improving safety and patient care. Shorla Oncology received an FDA approval for SH-105 (Tepylute) for patients with breast and ovarian cancers. 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. 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. 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.
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.”
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.
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. The FDA accepted the NDA for SH-201 in April 2024, with a potential approval decision expected by November.
July 1, 2024
