FDA Ok’s NDA for SH-105 in Breast and Ovarian Cancer

Cancer cells, malignant cells, generative ai illustration: © Dr_microbe - stock.adobe.com

• SH-105 is a ready-to-dilute formulation of a treatment for breast or ovary adenocarcinoma.
• The new formulation offers clinicians and patients easier access and administration of the agent.
• The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2024.

The FDA has accepted a new drug application (NDA) of SH-105, a ready-to-dilute formula of an existing treatment for adenocarcinoma of the breast or ovary. The PDUFA target action date is June 24, 2024.¹

“This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, in a press release.

The original agent SH-105 improved upon was approved in the 1950s and has not been updated since, according to Ryan.² The ready-to-dilute formulation simplifies the drug reconstitution process, which can improve efficiency and reduce preparation risks for clinicians, therefore increasing satisfaction and safety for patients.

Shorla Oncology has several other agents in its development pipeline. SH-110 is an oral treatment for glioma, and the company has had a pre-investigational new drug application meeting with the FDA. SH-201 is an oral treatment for chronic myeloid leukemia, acute lymphoblastic leukemia (ALL), myelodysplastic syndrome, and gastrointestinal tumors. The company plans to submit an NDA to the FDA for SH-201 in Q1 of this year. The company also manufactuers Jylamvo, the only approved, oral methotrexate solution for adults, and nelarabine, an injection for the treatment of T-cell ALL and T-cell lymphoblastic lymphoma.³

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 9, 2024. http://tinyurl.com/59ksrpnj

2. Ireland’s Shorla nabs $8.3m to bring improved cancer meds to the U.S. News release. Fierce Biotect. June 3, 2020. Accessed January 9, 2024. http://tinyurl.com/yhbbm4at

3. Shorla Oncology. Accessed January 9, 2024. https://shorlaoncology.com