OGSIVEO nirogacestat

Drug Class

Gamma-secretase inhibitor

Mechanism

Inhibits gamma-secretase activity to block cleavage of Notch receptors, preventing activation of Notch signaling pathways that promote desmoid tumor proliferation.

Approved Indication

FDA-approved for adult patients with progressing desmoid tumors who require systemic treatment.

What This Means For Patients

OGSIVEO is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2023) — Sources

Pivotal Clinical Evidence

• DeFi — Gounder et al., N Engl J Med 2023 (NCT03785964) — Sources

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nirogacestat-desmoid-tumors
• https://www.springworkstx.com/media/