WILMINGTON, DE — AstraZeneca has launched ZEGFROVY (sunvozertinib) in the United States for adults with a specific form of advanced lung cancer that has progressed following platinum-based chemotherapy, expanding access to an oral targeted treatment for patients with limited therapeutic options.
The medicine is approved for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors carry epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as identified by an FDA-approved diagnostic test.
The U.S. Food and Drug Administration granted accelerated approval based on tumor response data from the WU-KONG1B clinical trial. Continued approval may depend on a confirmatory study demonstrating clinical benefit.
In the open-label trial, ZEGFROVY produced a confirmed overall response rate of 46% among 85 patients. The median duration of response was 11.1 months among the 39 patients whose tumors responded to treatment.
Of those responding patients, 72% maintained their response for at least six months, according to AstraZeneca.
The findings supported accelerated approval, a regulatory pathway that permits earlier availability of certain medicines for serious conditions based on measures considered reasonably likely to predict clinical benefit.
EGFR exon 20 insertion mutations represent a distinct subtype of non-small cell lung cancer that has historically been difficult to treat with targeted therapies. AstraZeneca cited real-world evidence indicating five-year overall survival rates as low as 8% among affected patients.
ZEGFROVY is administered as a 200-milligram oral dose once daily with food. It is the only approved oral, single-agent targeted therapy for this patient population following platinum-based chemotherapy, according to the company.
“Patients with EGFR exon 20 insertion-mutated lung cancer have historically had limited targeted treatment options, particularly after their disease progresses following platinum-based chemotherapy,” stated Dr. D. Ross Camidge, director of thoracic oncology at the University of Colorado.
The medicine is included in the National Comprehensive Cancer Network’s clinical practice guidelines as a Category 2A recommended subsequent treatment option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC.
ZEGFROVY carries warnings for potentially severe or life-threatening adverse reactions, including interstitial lung disease and pneumonitis, which involve inflammation of lung tissue.
Other significant risks include severe diarrhea, nausea, vomiting, skin reactions and ocular complications, including keratitis, blurred vision and visual impairment. The medicine can also cause fetal harm when administered during pregnancy.
AstraZeneca is pursuing a broader indication for sunvozertinib as an initial treatment for patients with EGFR exon 20 insertion-mutated lung cancer.
The company has submitted supplemental regulatory applications to the FDA and China’s Center for Drug Evaluation based on results from the Phase III WU-KONG28 trial, which were presented at the American Society of Clinical Oncology’s annual meeting.
Both regulatory agencies have granted Breakthrough Therapy Designation for the medicine in the first-line treatment setting. That designation is intended to facilitate the development and review of therapies that may offer substantial improvement over existing treatments, but does not constitute approval for the additional indication.
ZEGFROVY is now available in the United States through its specialty distribution and pharmacy network. Eligible health systems may also obtain the medicine through their own specialty pharmacies.
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