Breaking Ground: Successful Treatment Options for RET-Positive Lung Cancer
The FDA accelerated approval of sunvozertinib for adult patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations following progression on platinum-based chemotherapy.
The U.S. Food and Drug Administration (FDA) granted accelerated approval to the oral EGFR‑TKI sunvozertinib for adult patients with advanced or metastatic non‑small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations after platinum‑based chemotherapy. The approval was based on the WU‑KONG1B (NCT03974022) single‑arm phase II study that enrolled 85 previously treated metastatic NSCLC patients, reporting a 46 % objective response rate and durable responses lasting nearly one year for many patients. The therapy’s side‑effect profile included gastrointestinal toxicities, skin rash, mouth sores, eye problems, fatigue, and pneumonitis.
EGFR exon 20 insertion mutations represent about 10% of all EGFR mutations in NSCLC and have historically been refractory to first‑generation EGFR‑TKIs. Sunvozertinib provides a target‑specific, orally bioavailable option, expanding treatment possibilities for a patient group that lacks effective post‑first‑line therapies.
Bizonyítékszint: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
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