Here’s a breakdown of the information provided in the text:
Shorla Oncology’s New Drug Approval:
Drug Name: SH-110
Indication: Glioma (a type of brain cancer)
Status: Recently approved by regulators.
Significance: Described as a “difference-maker” for glioma patients, complementing Shorla’s other treatments by being easier for patients, caregivers, and providers to use and administer.
Portfolio: SH-110 is Shorla’s third oral liquid cancer therapy,emphasizing their focus on accessible,safe,and user-kind treatments.
Orphan Drug Designation: SH-110 has received orphan drug designation from the FDA. This status is for drugs treating rare diseases affecting fewer than 200,000 people in the US and provides incentives like tax credits, user fee waivers, and market exclusivity.
other Shorla Liquid Suspension Treatments:
Jylamvo:
Active Ingredient: Oral methotrexate.
Indications: Acute lymphoblastic leukemia (ALL) and other cancers, as well as autoimmune diseases.
FDA Approval: Initially approved in November 2022 for select adult uses (ALL, cutaneous T-cell lymphoma, relapsed/refractory non-hodgkin lymphoma).
Expanded Approval: In October 2024,approval was expanded to include children with ALL.
Formulation: Orange-flavored liquid, designed to eliminate the need for pill splitting, crushing, or compounding.
Mechanism: Methotrexate works by blocking folic acid use in cells, hindering DNA production and helping to destroy cancer cells and reduce immune activity. Stability: Stable at room temperature for 90 days, eliminating the need for cold chain storage before dispensing.
Quote: Emphasizes addressing unmet needs in pediatric oncology and autoimmune diseases, offering a convenient choice for both adult and pediatric patients.
Imkeldi:
Active Ingredient: Liquid version of imatinib.
Indications: ALL,chronic myeloid leukemia,gastrointestinal stromal tumors,and other cancers.
FDA Approval: Approved in November 2024.
Key Themes:
Patient-Centricity: Shorla’s focus on developing oral liquid formulations that improve ease of use and governance for patients, caregivers, and providers.
Accessibility: Making cancer therapies more accessible through convenient formulations.
Addressing Unmet Needs: Developing treatments for rare diseases and expanding options for pediatric patients.
* Innovation: Creating novel formulations that offer advantages over traditional pill forms.
References:
The text cites three press releases from shorla Oncology as sources for the information.