Dizal's Zegfrovy (sunvozertinib) has won accelerated approval in the US for NSCLC with EGFR exon 20 insertion mutations after progression on or after platinum-based chemotherapy.
The nod was for a lower dose than that in China, where the once-daily oral EGFR inhibitor received conditional approval in the same indication in 2023, based on a China-only trial.
Results from a global pivotal study testing 200mg and 300mg dosages showed roughly the same efficacy.
First-line Phase III study also fully enrolled.

Dizal’s Zegfrovy Wins US NSCLC Approval, At Lower Dose Than In China

New Once-Daily Oral Option