The FDA has accepted a New Drug Application (NDA) for SH-105, a ready-to-dilute formulation of an existing treatment for adenocarcinoma of the breast or ovary. This updated formulation, developed by Shorla Oncology, aims to simplify the drug reconstitution process, improve efficiency for clinicians, and enhance safety and satisfaction for patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2024.
Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, stated that this innovative drug will offer hospital pharmacists and patients access to a differentiated, ready-to-administer, injectable product with unique characteristics, expected to facilitate rapid adoption upon approval.
Addressing Unmet Needs in Cancer Treatment
The original agent upon which SH-105 is based was approved in the 1950s and has not been updated since. The ready-to-dilute formulation of SH-105 addresses the need for improved drug preparation and administration. By simplifying the reconstitution process, SH-105 has the potential to reduce preparation risks for clinicians and increase safety for patients.
Shorla Oncology's Pipeline
In addition to SH-105, Shorla Oncology has several other agents in its development pipeline. SH-110 is an oral treatment for glioma, for which 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 manufactures 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.
