The U.S. Food and Drug Administration (FDA) has granted approval for TEPYLUTE 100mg/10mL, a novel ready-to-dilute multi-dose formulation of thiotepa developed by Shorla Oncology for the treatment of breast and ovarian cancer. This approval represents a significant advancement over the traditional freeze-dried powder formulation of thiotepa, which has been in use since the 1950s.
TEPYLUTE's innovative formulation eliminates the need for reconstitution, potentially reducing preparation time and minimizing the risk of dosing errors. Notably, once opened, the 100mg vial remains stable for 14 days when properly stored, providing healthcare facilities with greater flexibility in treatment scheduling and administration.
"We are pleased to offer another viable treatment option for patients with breast and ovarian cancer," said Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology. "Once opened, our 100mg vial of TEPYLUTE is stable for 14 days when properly stored, giving providers the flexibility they need when preparing and administering this very important treatment."
Clinical Significance and Market Impact
Thiotepa, an alkylating agent first approved by the FDA in 1959, remains a standard-of-care treatment for adenocarcinoma of the breast and ovary. The new formulation addresses longstanding challenges associated with the traditional freeze-dried powder presentation.
"This is a huge win for providers because TEPYLUTE avoids the need for complicated and time-consuming reconstitution," explained Orlaith Ryan, Chief Technical Officer and Co-Founder of Shorla Oncology.
Rayna Herman, Chief Commercial Officer at Shorla Oncology, emphasized the patient-centered benefits: "We are excited to bring TEPYLUTE to the US Market. It provides consistent dosing accuracy and allows for 'just in time' preparation, which benefits everyone, especially patients."
Along with the approval of the multi-dose vial, Shorla Oncology has also announced the commercial launch of both 15mg and 100mg vials of TEPYLUTE in the United States, expanding treatment options for oncologists and their patients.
Disease Burden and Unmet Need
The approval addresses significant medical needs in women's oncology. According to the American Cancer Society, more than 300,000 women will be diagnosed with breast cancer in the U.S. in 2025, while approximately 20,890 women will receive an ovarian cancer diagnosis during the same period.
TEPYLUTE joins Shorla Oncology's growing portfolio of oncology products in the U.S. market, which includes Nelarabine for T-cell leukemia, JYLAMVO for acute lymphoblastic leukemia, and IMKELDI for chronic myeloid leukemia and gastrointestinal stromal tumors.
Safety Profile and Administration
As with the original thiotepa formulation, TEPYLUTE carries important safety considerations. The most common adverse reactions include neutropenia, anemia, thrombocytopenia, elevated liver enzymes, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria, and rash.
Clinically significant adverse reactions include myelosuppression, infection, hypersensitivity, cutaneous toxicity, hepatic veno-occlusive disease, central nervous system toxicity, and carcinogenicity. The prescribing information includes a boxed warning regarding these risks.
The recommended dosage of TEPYLUTE is 0.3 mg/kg to 0.4 mg/kg administered intravenously at 1- to 4-week intervals. Maintenance doses should be adjusted weekly based on pretreatment control blood counts and subsequent monitoring, and should not be administered more than once weekly.
Pharmaceutical Innovation and Patient Access
TEPYLUTE represents a continuation of Shorla Oncology's mission to address areas where existing treatments are limited, in shortage, or inadequately formulated for target populations. The U.S.-Ireland based specialty pharmaceutical company has focused its development pipeline on innovative oncology drugs for orphan and pediatric cancers.
The approval of TEPYLUTE 100mg multi-dose vial highlights the ongoing importance of pharmaceutical innovation in improving not only treatment efficacy but also the practical aspects of drug administration and patient care. By addressing the preparation challenges associated with traditional thiotepa formulations, TEPYLUTE may contribute to more efficient workflow in oncology treatment centers while maintaining the established therapeutic benefits of this important medication.
