FDA Approves New Drug Application for Shorla Oncology’s Tepylute, a Ready-to-Dilute Formulation for the Treatment of Breast and Ovarian Cancer

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The FDA has approved Shorla Oncology’s Tepylute, a ready-to-dilute formulation designed to treat breast and ovarian cancer. According to the company, the formulation is an easier to prepare injectable product that enables dosing accuracy, addressing the shortcomings and handling complexities associated with the current lyophilized powder formulation. Additionally, Shorla stated that the new formulation eliminates the need for complex and time-consuming reconstitution, enabling consistent dosing accuracy.¹

‘’This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation," said Sharon Cunningham, CEO, co-founder, Shorla Oncology, 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."

Tepylute is a liquid form of thiotepa, which is currently considered a standard of care oncology drug. The consistent dosing accuracy allows for "just in time" preparation.¹

"Among Tepylute’s many benefits, it removes the necessity to reconstitute which can introduce additional risks of drug preparation errors," stated Rayna Herman, chief commercial officer, Shorla Oncology, in the press release. "We look forward to providing an update on our launch plans for Tepylute in the near future."

Currently, there are multiple options for treating breast cancer, which include lumpectomy, mastectomy, sentinel node biopsy, radiation therapy, chemotherapy, hormone therapy, targeted therapy, immunotherapy, and palliative care. The Mayo Clinic encourages patients with breast cancer to consider all options, such as speaking with a specialist in a breast center of clinic.²

“Breast cancer treatment often starts with surgery to remove the cancer,” reports the Mayo Clinic. “Most people with breast cancer will have other treatments after surgery, such as radiation, chemotherapy and hormone therapy. Some people may have chemotherapy or hormone therapy before surgery. These medicines can help shrink the cancer and make it easier to remove. Your treatment plan will depend on your particular breast cancer. Your healthcare team considers the stage of the cancer, how quickly it's growing and whether the cancer cells are sensitive to hormones. Your care team also considers your overall health and what you prefer.”

According to the American Cancer Society, an estimated 19,680 will be diagnosed with ovarian cancer this year, with 12,740 dying. It is considered one of the leading causes of cancer deaths in women in the United States. On average, it is most common in women aged 63 years or older. Due to better treatments being on the market, the number of women dying from ovarian cancer has decreased by 40% since 1975, with most of these decreases coming in the 21st century.³

Treatment for ovarian cancer most commonly consists of surgery and chemotherapy. Operations include removing one ovary, both ovaries, both ovaries and the uterus, and advanced cancer surgery. Similar to breast cancer treatment, additional options also include targeted therapy, immunotherapy, hormone therapy, and palliative care.⁴

“Once it's confirmed that you have ovarian cancer, your doctor will use information from your tests and procedures to assign your cancer a stage,” reports the Mayo Clinic. “The stages of ovarian cancer range from 1 to 4, which are often indicated with Roman numerals I to IV. The lowest stage indicates that the cancer is confined to the ovaries. By stage 4, the cancer has spread to distant areas of the body.”

Shorla Oncology is currently marketing two other cancer products, which treat leukemia and other cancers.¹

"The approval of Tepylute represents an important milestone for Shorla as our first in-house developed NDA," said Orlaith Ryan, chief technical officer, co-founder, Shorla Oncology, in the press release.

References

1. Shorla Oncology Announces FDA Approval for TEPYLUTE, A Novel Formulation to Treat Breast and Ovarian Cancer. Yahoo!finance. June 28, 2024. Accessed July 1, 2024. https://finance.yahoo.com/news/shorla-oncology-announces-fda-approval-110000280.html

2. Breast cancer. Mayo Clinic. Accessed July 1, 2024. https://www.mayoclinic.org/diseases-conditions/breast-cancer/diagnosis-treatment/drc-20352475

3. Key Statistics for Ovarian Cancer. American Cancer Society. Accessed July 1, 2024. https://www.cancer.org/cancer/types/ovarian-cancer/about/key-statistics.html

4. Ovarian cancer. Mayo Clinic. Accessed July 1, 2024. https://www.mayoclinic.org/diseases-conditions/ovarian-cancer/diagnosis-treatment/drc-20375946