The FDA recently approved a new oral therapy, Zegfrovy (sunvozertinib) from Dizal (Jiangsu) Pharmaceutical Co., Ltd., for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Zegfrovy is the only approved targeted oral treatment for NSCLC with EGFR exon20ins. Zegfrovy will compete with Rybrevant, an infused therapy, in this patient segment. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Roughly 2% of NSCLC patients have the genetic type, though it is the third most common type of EGFR mutation.
Dizal has not announced the cost of Zegfrovy.
The company has not announced details for logistics or distribution.
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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
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