Tepylute for breast, ovarian cancer launched in US
FDA approves multi-dose, ready-to-dilute formulation
Tepylute (thiotepa), a chemotherapy medication from Shorla Oncology that was approved last year for treating certain breast and ovarian cancers, has launched in the U.S.
Given via infusions into the bloodstream by a healthcare provider, Tepylute is a liquid formulation of thiotepa, a standard chemotherapy that’s been used to treat cancer for decades.
The formulation initially approved by the FDA came in single-dose vials, but the regulators recently cleared a new, multi-dose vial formulation that can be prepared and stored for up to two weeks.
“We are excited to bring Tepylute to the US Market,” Rayna Herman, Shorla’s chief commercial officer, said in a company press release. “It provides consistent dosing accuracy and allows for “just in time” preparation, which benefits everyone, especially patients.”
Thiotepa belongs to a class of chemotherapies called alkylating agents, which work to kill cancer cells by damaging their DNA. It’s been used since the 1950s for treating various forms of cancer, and is available under the brand name Tepadina, with generics also available. But these formulations come as a freeze-dried powder that has to be reconstituted in liquid before use, which can be a time-consuming and error-prone process.
Breast, ovarian cancer treatment
Tepylute is designed to help reduce preparation time and errors by providing thiotepa that’s already in a liquid formulation, but it still has to be diluted in additional liquid before the infusion.
It was approved in the U.S. last summer for treating adenocarcinoma of the breast or ovary. Adenocarcinomas are cancers that grow from gland cells that line organs.
The most common type of ovarian cancer, ovarian adenocarcinoma is commonly treated with a combination of surgery to remove the cancer and chemotherapy to kill off remaining cancer cells.
Tepylute comes in single-use vials (15 mg/1.5 mL) and multi-use vials (100 mg/10 mL).
“We are pleased to offer another viable treatment option for patients with breast and ovarian cancer,” said Sharon Cunningham, Shorla CEO and co-founder. “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.”
Tepylute is usually given once every one to four weeks. The most common side effects associated with it include low blood cell counts, elevated liver enzymes, painful inflammation in the digestive tract (mucositis), cytomegalovirus infections, bleeding, diarrhea, bloody urine, and rash.
The American Cancer Society estimates that more than 300,000 women will be diagnosed with breast cancer in the U.S. in 2025, and more than 20,000 will be diagnosed with ovarian cancer. Tepylute could offer a new treatment option for these women.
Shorla also markets chemotherapy medications for certain blood cancers. Those medications include nelarabine and Jylamvo (methotrexate). The company also markets the targeted therapy Imkeldi (imatinib) to treat certain leukemias and other cancers.
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