Monday, July 15, 2024

Breast and Ovarian Cancer Treatment Advances with FDA Approval of Shorla Oncology’s Tepylute, a Ready-to-Dilute Formulation

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Breast and ovarian cancer treatment has advanced with the FDA’s approval of Shorla Oncology’s Tepylute, a ready-to-dilute formulation. This new formulation simplifies preparation, ensuring dosing accuracy and addressing the challenges associated with the current lyophilized powder formulation. Shorla Oncology emphasized that the ready-to-dilute format eliminates the need for complex and time-consuming reconstitution, enabling consistent dosing accuracy.

“This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” said Sharon Cunningham, CEO and co-founder of 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, a standard oncology drug. Its consistent dosing accuracy allows for “just in time” preparation. Rayna Herman, Chief Commercial Officer of Shorla Oncology, highlighted that Tepylute’s many benefits include removing the necessity to reconstitute, thereby reducing the risks of drug preparation errors. Herman also mentioned that they look forward to providing updates on their launch plans for Tepylute.

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 advises patients with breast cancer to consider all options and consult with specialists in a breast center or clinic.

“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 to 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 your preferences.”

According to the American Cancer Society, an estimated 19,680 women will be diagnosed with ovarian cancer this year, with 12,740 expected to die from the disease. Ovarian cancer is one of the leading causes of cancer deaths among women in the United States, most commonly affecting women aged 63 years or older. Due to advancements in treatment, the number of women dying from ovarian cancer has decreased by 40% since 1975, with most of these decreases occurring in the 21st century.

Treatment for ovarian cancer typically involves surgery and chemotherapy. Surgical options 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.

Breast and Ovarian Cancer

Staging in Breast and Ovarian Cancer: Understanding Diagnosis and Disease Progression

“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, 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. “The approval of Tepylute represents an important milestone for Shorla as our first in-house developed NDA,” said Orlaith Ryan, Chief Technical Officer and co-founder of Shorla Oncology, in the press release.

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The FDA approval of Tepylute marks a significant advancement in the treatment of breast and ovarian cancer. This ready-to-dilute formulation not only simplifies the preparation process but also ensures consistent dosing accuracy, which is crucial for effective treatment. By eliminating the need for complex reconstitution, Tepylute reduces the risk of preparation errors and minimizes exposure to hazardous drugs for medical personnel.

Breast cancer treatments have evolved significantly over the years, with a range of surgical and non-surgical options available. The initial step often involves surgery to remove the cancer, followed by treatments such as radiation, chemotherapy, and hormone therapy. The choice of treatment depends on various factors, including the stage and growth rate of the cancer, hormone sensitivity, and the overall health of the patient.

Similarly, ovarian cancer treatment primarily involves surgery and chemotherapy, with additional options such as targeted therapy, immunotherapy, and hormone therapy available. The staging of ovarian cancer, ranging from I to IV, helps determine the extent of the disease and guide treatment decisions.

Shorla Oncology’s development and approval of Tepylute demonstrate their commitment to improving cancer treatment options. By addressing the limitations of existing formulations and enhancing the ease of use for medical professionals, Shorla Oncology aims to improve patient outcomes and streamline the treatment process in oncology clinics and hospitals.

Overall, the approval of Tepylute represents a significant step forward in the fight against breast and ovarian cancer. With its ready-to-dilute formulation, Tepylute offers a safer, more efficient, and accurate treatment option, benefiting both patients and healthcare providers. Shorla Oncology’s innovative approach continues to contribute to the advancement of cancer care, providing hope and improved quality of life for patients worldwide.

 

Resource: Mayo Clinic, July 01, 2024

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