FDA Receives New Drug Application for SH-105 in Breast and Ovarian Cancer

Developers designed SH-105 as a ready-to-dilute formulation of a previously approved drug that has been used as a freeze-dried powder for the management of adenocarcinoma of the breast or ovary.

A new drug application (NDA) for SH-105 as a treatment for those with breast cancer or ovarian cancer has been submitted to and accepted by the FDA, according to a press release from Shorla Oncology.¹

The regulatory agency has set a Prescription Drug User Fee Act date of June 29, 2024 for their decision on SH-105 in the aforementioned patient populations.

Developers designed SH-105 as a ready-to-dilute formulation of a previously approved drug that has been used as a freeze-dried powder for the management of adenocarcinoma of the breast or ovary. The new formulation is believed to remove the need to reconstitute the powder based on its novel, differentiated liquid form, thereby improving efficiency and reducing the complexity associated with its preparation.

“This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics [which is] expected to facilitate rapid adoption once approved,” Orlaith Ryan, chief technical officer and co-founder at Shora Oncology, said in the press release.¹

Manufacturers organized a successful pre–investigational new drug meeting with the FDA for SH-105 in June 2019.² Developers stated that this “positive outcome strengthens [their] efforts to bring SH-105 to market benefiting [patients with] breast and ovarian cancer” and described the meeting as a “significant milestone on Shorla Oncology’s journey of bringing innovative oncology products to market.”²

According to the manufacturers, SH-105 is one of many oncology agents that comprise the company’s pipeline. Previously, the FDA approved nelarabine (Arranon) injection for treating those with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in March 2023.³ The nelarabine injection was designed to provide an alternative formulation of a product that may be in short supply.

“Successful treatment of children, adolescents and young adults with cancer, such as children with T-cell acute lymphoblastic leukemia, is dependent on stable access to critical chemotherapy agents,” Stephen P. Hunger, MD, chief of the Division of Oncology and director of the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia, said in a press release on the approval of the injection.³ “Drug shortages directly impact patient outcome. We are encouraged by the approval of nelarabine injection and the significant impact that we expect it will have on treatment access and patient care.”

Shora Oncology also announced a successful pre-investigational new drug application meeting with the FDA for SH-110, a novel agent for managing brain cancer, in October 2020.⁴ According to the developers, SH-110 may provide a significant benefit to those with brain cancer by diminishing the burden of treatment while offering an age-appropriate treatment.

“This is an important step in improving access to and administration of a drug that will help [patients with] breast and ovarian cancer. It also marks a significant milestone regarding Shorla’s efforts to bring innovative oncology products to market,” Sharon Cunningham, chief executive officer and co-founder at Shorla Oncology, said regarding the NDA submission for SH-105.¹

References

1. Shorla Oncology announces FDA Filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. January 9, 2024. Accessed January 11, 2024. https://shorturl.at/arv45
2. SH-105 successful FDA pre-IND meeting. News release. Shorla Oncology. June 14, 2019. Accessed January 11, 2024. https://shorturl.at/bftOP
3. Shorla Oncology announces U.S. FDA approval of nelarabine injection for the treatment of T-cell leukemia. News release. Shorla Oncology. March 7, 2023. Accessed January 11, 2024. https://shorturl.at/FU234
4. SH-110 successful FDA pre-IND meeting. News release. Shorla Oncology. October 2, 2020. Accessed January 11, 2024. https://shorturl.at/guwIM