SH-110, a liquid cancer treatment for glioma, earned orphan drug status from the FDA, helping patients who struggle to swallow pills access therapy.
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SH-110, a liquid medication designed to treat glioma, a rare form of brain cancer. This designation is a significant step for patients who struggle to swallow pills.
This new liquid formulation addresses a critical need. “For too long, many patients with glioma and their pharmacists and caregivers had no other choice but to break open capsules and expose themselves to unnecessary hazards,” said Sharon Cunningham, CEO. “SH-110 is a proprietary product that offers them a safer and more convenient formulation to treat this rare brain cancer.”
A More Accessible Treatment Option
Glioma affects approximately 13,000 adults and 2,000 children annually in the U.S., according to the National Brain Tumor Society. SH-110 promises to improve treatment flexibility and accessibility for these patients.
Beyond broader dosing and administration options, SH-110’s most substantial benefit is for individuals with dysphagia, or difficulty swallowing. These patients often rely on specialized compounding pharmacies or must alter their medications themselves. SH-110 will join an expanding portfolio of patient-focused cancer therapies.
“This is a difference-maker in the lives of those who suffer from glioma,” stated Orlaith Ryan, chief technical officer and co-founder. “SH-110 complements our other treatments designed to be easier for patients and caregivers to use.”
SH-110 is the third oral liquid therapy from the company, reinforcing its commitment to enhancing both safety and usability in cancer treatment.
Orphan drug designation is granted by the FDA to drugs targeting rare diseases affecting fewer than 200,000 people in the U.S. It offers incentives like tax credits and market exclusivity.
Expanding Liquid Suspension Treatments
The company also offers Jylamvo, an oral methotrexate for acute lymphoblastic leukemia (ALL) and other cancers, and Imkeldi, a liquid version of imatinib for ALL, chronic myeloid leukemia, and gastrointestinal stromal tumors. Jylamvo received initial FDA approval in November 2022 for specific adult indications. Its approval was expanded in October 2024 to include pediatric ALL treatment.
Jylamvo, an orange-flavored liquid methotrexate, eliminates the need for pill splitting or crushing. Methotrexate works by hindering cells’ ability to use folic acid for DNA synthesis, thereby targeting cancer cells and reducing immune activity.
Notably, Jylamvo remains stable at room temperature for 90 days, removing the need for cold chain storage. “This approval represents a critical step forward in addressing the unmet need of pediatric care in oncology,” said Cunningham in a previous statement. “We are pleased to offer a convenient, patient-friendly alternative.” Imkeldi gained FDA approval in November 2024.
