Eight years after its founding, partly backed by AstraZeneca, Dizal Pharmaceuticals has secured its first FDA approval, receiving accelerated clearance for ZEGFROVY (sunvozertinib)—now the only FDA-approved oral therapy for a rare subset of non-small cell lung cancer (NSCLC).
The treatment is indicated for U.S. patients with EGFR exon 20 insertion mutations whose cancer has progressed after platinum-based chemotherapy. This milestone follows 16 months after the FDA approved Johnson & Johnson’s RYBREVANT, an infused EGFR-MET bispecific antibody, for first-line treatment in combination with chemotherapy. Unlike Rybrevant, ZEGFROVY is a first-in-class, selective E...
