FDA Approves Ready-to-Dilute Tepylute for Breast and Ovarian cancer

The FDA granted approval to treatment with Tepylute at 100 mg for breast and ovarian cancers: © stock.adobe.com.

The U.S. Food and Drug Administration (FDA) has approved treatment with 100 milligrams of Tepylute (formerly SH-105) for breast and ovarian cancers, according to a press release from Shorla Oncology.

Tepylute is a ready-to-dilute version of thiotepa, a standard drug used to treat breast and ovarian cancer. This new formulation may save time and reduce preparation errors by eliminating reconstitution and offering more scheduling flexibility. Since the 1950s, thiotepa has been manufactured as a freeze-dried powder.

“We are pleased to offer another viable treatment option for patients with breast and ovarian cancer,” Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, said in the press release. “Once opened, our 100-milligram 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.

The approval includes 100- and 15-milligrams vials of Tepylute in the United States.

“This is a huge win for providers because Tepylute avoids the need for complicated and time-consuming reconstitution,” Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, said in the press release.

According to FDA, the most common side effects of thiotepa include neutropenia, anemia, thrombocytopenia, increased liver enzymes, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.

Warnings in the prescribing information highlight myelosuppression and carcinogenicity risks. Tepylute may cause severe marrow suppression, and high doses could lead to marrow ablation, resulting in infection or bleeding; monitoring hematologic parameters is advised.

The recommended thiotepa dose is 0.3 mg/kg to 0.4 mg/kg intravenously — through the vein — in intervals of one to four weeks. Maintenance doses should be adjusted weekly based on blood counts and should not exceed once per week.

Tepylute is contraindicated in patients with severe hypersensitivity to thiotepa and when used with live or attenuated vaccines.

“We are excited to bring Tepylute to the U.S. market. It provides consistent dosing accuracy and allows for “just in time” preparation, which benefits everyone, especially patients.” said Rayna Herman, chief commercial officer of Shorla Oncology, in another news release.

In June 2024, the FDA approved a new drug application for a ready-to-dilute formulation of Tepylute for the treatment of patients with adenocarcinoma of the breast and ovary.

More Information on Breast and Ovarian Cancer

Breast cancer forms in breast tissue, according to the National Cancer Institute. The most common type is ductal carcinoma, which starts in the milk ducts. Another type is lobular carcinoma, which begins in the milk glands. Invasive breast cancer spreads from the ducts or lobules to surrounding tissue. While it occurs in both men and women, male breast cancer is rare.

Furthermore, ovarian cancer forms in the tissues of the ovary, one of the female reproductive glands where eggs are produced. Most ovarian cancers are either epithelial or malignant germ cell tumors. Fallopian tube and primary peritoneal cancers are similar to ovarian epithelial cancer and are staged and treated the same.

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