FDA Approves New Drug Application for Tepylute to Treat Breast, Ovarian Cancer


Tepylute is a ready-to-dilute, injectable formula that reduces preparation time and enable dosing accuracy.

The new drug application for Tepylute, formerly SH-105, was approved by the FDA for the treatment of patients with breast cancer (BC) or ovarian cancer (OC). Tepylute is a novel ready-to-dilute formulation that removes the need to reconstitute treatments, saving clinicians preparation time and preventing the additional risks of drug preparation efforts. The new formulation has multiple benefits for medical personnel and patients alike, offering less-invasive treatment options and providing more consistent dosing.

breast and ovarian cancer

These formulation advancements offer patients with safer, less-invasive medication administration, potentially improving treatment times, treatment locations, and quality-of-care. Image Credit: © motortion - stock.adobe.com

According to the National Breast Cancer Foundation, 1 in 8 women will be diagnosed with breast cancer in their lifetimes in the United States, with approximately 310,720 diagnoses expected in 2024. BC is highly treatable due to advances in early detection and treatment, significantly increasing survival rates and treatment success for patients.1

OC is less common, accounting for about 2.5% of cancers in women. However, it has considerably poorer outcomes compared with BC, with a relative survival rate of 50.8% at 5 years. OC is also significantly harder to detect due to obscure symptoms and lack of routine screening options to detect it in its early stages. Approximately 70% to 80% of patients already have stage 3 or 4 OC by the time of diagnosis, greatly compromising their treatment outcomes.2,3

Tepylute is the liquid form of thiotepa (Tepadina; Amneal Pharmaceuticals), an alkylating agent that works by attaching to a DNA stand on the cancer cell, preventing the division and proliferation of malignant cells. Thiotepa, in its original form, is a nonpyrogenic, sterile, white lyophilized powder or lyophilized cake for intravenous, intracavitary, or intravesical use after reconstitution and dilution. The new formulation for thiotepa makes it easier for oncology clinics and hospitals to prepare and administer to patients.4-6

Alongside the approval of tepylute, the FDA also accepted SH-201, an oral liquid therapy treatment for various cancers, which has an expected action date of November 30, 2024. These formulation advancements offer patients with safer, less-invasive medication administration, potentially improving treatment times, treatment locations, and quality-of-care.4,7

‘’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 a press 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.”4


1. Breast cancer facts & stats. National Breast Cancer Foundation, Inc. April 25, 2024. Accessed June 28, 2024. https://www.nationalbreastcancer.org/breast-cancer-facts/

2. Ovarian cancer statistics. Ovarian Cancer Research Alliance. Accessed June 28, 2024. https://ocrahope.org/get-the-facts/statistics/#:~:text=A%20woman's%20lifetime%20risk%20of,cancer%20is%201%20in%20130.

3. How is ovarian cancer diagnosed? MD Anderson Cancer Center. February 23, 2023. Accessed June 28, 2024. https://www.mdanderson.org/cancerwise/how-is-ovarian-cancer-diagnosed.h00-159616278.html

4. Shorla oncology announces FDA approval for TEPYLUTE, a novel formulation to treat breast and ovarian cancer. Business Wire. June 28, 2024. Accessed 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

5. Thiotepa (tepadine). Cancer Research UK. Accessed June 28, 2024. https://www.cancerresearchuk.org/about-cancer/treatment/drugs/thiotepa#:~:text=Thiotepa%20is%20a%20type%20of,divide%20into%202%20new%20cells.

6. Thiotepa prescribing information. Drugs.com. January 3, 2024. Accessed June 28, 2024. https://www.drugs.com/pro/thiotepa.html#:~:text=Thiotepa%20for%20Injection%2C%20USP%20is,use%20after%20reconstitution%20and%20dilution.

7. FDA accepts NDA for SH-201 in leukemia and other cancers. OncLive. April 8, 2024. Accessed June 28, 2024. https://www.onclive.com/view/fda-accepts-nda-for-sh-201-in-leukemia-and-other-cancers

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