FYARRO sirolimus protein-bound particles

Drug Class

mTOR kinase inhibitor

Mechanism

Inhibits downstream signals of mTORC1 activation, inducing cell-cycle arrest and apoptosis in tumor cells highly sensitive to mTOR alterations.

Approved Indication

FDA-approved for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

What This Means For Patients

FYARRO 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 (2021) — Sources

Pivotal Clinical Evidence

• AMPECT — Wagner et al., J Clin Oncol 2021 (NCT02494570) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213978s000lbl.pdf