FDA Approves New Formulation of Thiotepa for Patients With Breast and Ovarian Cancer
On June 28, 2024, the US Food and Drug Administration (FDA) approved the new drug application for SH-105, a liquid, ready-to-dilute form of thiotepa, for the treatment of patients with breast and ovarian cancer. The current formulation of thiotepa is a lyophilized powder.
According to the company producing SH-201, Shorla Oncology, this new formulation enables dosing accuracy and makes the drug easier to administer while reducing healthcare personnel exposure to a hazardous agent.
The recommended dose of SH-105 for the treatment adenocarcinoma of the breast or ovary is 0.3 mg/kg to 0.4 mg/kg intravenously in 1-to-4–week intervals followed by maintenance intervals, to be adjusted weekly based on pre-treatment control blood counts and subsequent blood counts.
The most common adverse reactions occurring in >10% of patients included neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria, and rash.
The prescribing information includes a Boxed Warning for severe marrow suppression or ablation with resulting infection or bleeding that should be monitored using hematologic laboratory parameters.
Source:
Shorla oncology announces FDA approval for TEPYLUTE, a novel formulation to treat breast and ovarian cancer. Published online: 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
Highlights of Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216984s000lbl.pdf
