FDA approves liquid formulation of thiotepa for breast, ovarian cancers
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The FDA approved a new liquid formulation of thiotepa for the treatment of adults with adenocarcinoma of the breast or ovary, according to press release from the agent’s manufacturer.
Tepylute (SH-105; Shorla Oncology) is a liquid version of the alkylating agent thiotepa designed to be diluted and used as an injectable treatment. Thiotepa received original approval for its IV formulation in 1959 for both breast and ovarian cancer.
"This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” Sharon Cunningham, CEO and co-founder of Shorla Oncology, said in the 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.”
Tepylute carries a black box warning from the FDA advising that it may cause severe myelosuppression resulting in bleeding or infection and that providers should monitor recipients with hematologic laboratory testing. It also warns of the known risk for secondary malignancies associated with alkylating agents.
“Among Tepylute’s many benefits, it removes the necessity to reconstitute, which can introduce additional risks of drug preparation errors,” Rayna Herman, chief commercial officer of Shorla Oncology, said in the release. “We look forward to providing an update on our launch plans for Tepylute in the near future.”
The most common adverse events associated with the use of Tepylute include neutropenia, anemia, thrombocytopenia, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria, rash and elevated levels of alanine aminotransferase, aspartate aminotransferase, and bilirubin.
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