索托拉西布 sotorasib

Drug Class

KRAS G12C inhibitor

Mechanism

Inhibits KRAS G12C by covalently and irreversibly binding to the unique cysteine residue in the inactive GDP-bound state, locking the protein in the inactive state and blocking downstream oncogenic signaling.

Approved Indication

Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.

What This Means For Patients

索托拉西布 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
• EMA — Approved (2022) — Sources

Pivotal Clinical Evidence

• CodeBreaK 100 — Skoulidis et al., N Engl J Med 2021 (NCT03600883) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/lumykras