Dizal Set to Bring Lung Cancer Drug Zegfrovy to US

Dizal set to bring lung cancer drug Zegfrovy to US

Dizal gets US approval for an oral therapy for EGFR exon 20-mutated NSCLC, offering some patients an alternative to J&J's intravenous Rybrevant

Dizal's ZEGFROVY® (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20insApproval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which ZEGFROVY demonstrated statistically significant and clinically meaningful benefits to…

Investigational Oral EGFR Inhibitor Shows Promising Efficacy in Pretreated NSCLC

The investigational agent, zipalertinib, received the breakthrough designation from the FDA in January 2022

FDA approves Dizal's Zegfrovy to treat adults with NSCLC

Dizal has received FDA approval for Zegfrovy to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

Sunvozertinib Granted FDA Accelerated Approval in EGFR Exon 20+ NSCLC

Sunvozertinib has received accelerated approval for use in advanced or metastatic non–small lung cancer harboring EGFR exon 20 insertion mutations.

Sunvozertinib Earns FDA Accelerated Approval in EGFR Exon 20+ NSCLC

Data from the phase 1/2 WU-KONG1 study support the accelerated approval of sunvozertinib in this population.