The FDA has granted approval to Tepylute (thiotepa), a ready-to-dilute injectable formulation developed by Shorla Oncology, for the treatment of breast and ovarian cancer. This approval addresses the challenges associated with the previous lyophilized powder formulation, offering a more convenient and safer option for healthcare providers. The new formulation simplifies the drug reconstitution process, enhances dosing accuracy, and reduces the risk of exposure to this hazardous drug for medical personnel.
Addressing Unmet Needs in Cancer Treatment
Tepylute, formerly known as SH-105, represents a significant advancement in the administration of thiotepa, a well-established chemotherapy drug. The ready-to-dilute formulation eliminates the need for complex and time-consuming reconstitution, allowing for "just in time" preparation and consistent dosing. According to Shorla Oncology, this innovation reduces the potential for drug preparation errors, a critical factor in chemotherapy administration.
Sharon Cunningham, CEO and Co-Founder of Shorla Oncology, stated that this approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation. She added, "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."
Clinical Significance and Impact
The American Cancer Society estimates that over 300,000 women will be diagnosed with breast cancer in the U.S. in 2024, and approximately 19,680 women will be diagnosed with ovarian cancer. Thiotepa is a crucial treatment option for these cancers, often used in high-dose chemotherapy regimens followed by stem cell transplantation. The availability of Tepylute is expected to streamline the treatment process and improve patient safety.
Shorla Oncology's Growing Portfolio
Tepylute is the third FDA-approved drug for Shorla Oncology and their first in-house developed NDA. The company is also advancing its pipeline with SH-201, a palatable oral liquid treatment for certain forms of leukemia and other cancers. The FDA has accepted SH-201 for NDA review, with an expected action date of November 30, 2024. Shorla Oncology currently markets two products: Nelarabine for T-cell leukemia and JYLAMVO for acute lymphoblastic leukemia.
Orlaith Ryan, Chief Technical Officer and Co-Founder of Shorla Oncology, emphasized the importance of this milestone, stating, "The approval of Tepylute represents an important milestone for Shorla as our first in-house developed NDA."
Rayna Herman, Chief Commercial Officer, highlighted the benefits of Tepylute, noting that it removes the necessity to reconstitute, which can introduce additional risks of drug preparation errors. The company anticipates providing an update on their launch plans for Tepylute in the near future.
