WILMINGTON, Del. — AstraZeneca announced Thursday that its targeted lung cancer treatment ZEGFROVY (sunvozertinib) is now available in the United States for adults with a specific genetic mutation associated with advanced non-small cell lung cancer (NSCLC).
The oral medication is approved for patients with locally advanced or metastatic NSCLC whose tumors carry epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as confirmed by an FDA-approved test, and whose disease has progressed during or after platinum-based chemotherapy.
ZEGFROVY is the only approved oral, single-agent targeted therapy for this patient population following platinum-based chemotherapy, according to AstraZeneca.
The U.S. Food and Drug Administration granted accelerated approval to ZEGFROVY based on results from the WU-KONG1B clinical trial, which evaluated the treatment in patients with EGFR exon 20 insertion-mutated lung cancer.
In the study, the drug demonstrated a confirmed overall response rate of 46% among 85 patients. The median duration of response was 11.1 months among the 39 patients who responded to treatment.
Approximately 72% of responding patients maintained their response for at least six months.
The accelerated approval pathway allows treatments addressing serious medical conditions to reach patients based on early evidence of clinical benefit. Continued approval may depend on additional clinical trials confirming the treatment’s effectiveness.
EGFR exon 20 insertion mutations represent a particularly challenging form of EGFR-mutated lung cancer. Patients with these mutations have historically faced limited targeted treatment options and poor long-term outcomes.
According to AstraZeneca, real-world evidence has shown five-year overall survival rates as low as 8% among patients with this form of lung cancer.
“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,” said Dr. D. Ross Camidge, director of thoracic oncology at the University of Colorado.
“For these patients, sunvozertinib (ZEGFROVY) offers an oral, once-daily targeted treatment option that is recommended in clinical practice guidelines – giving patients and clinicians an option when treatment choices have historically been limited,” Camidge added.
Mohit Manrao, senior vice president of U.S. oncology at AstraZeneca, said the commercial launch represents an expansion of the company’s portfolio of treatments targeting EGFR mutations.
“As a leader in treating EGFR-mutated lung cancer, the US launch of ZEGFROVY marks an important step forward in our commitment to this patient community,” Manrao said.
“By making ZEGFROVY available in the US, we are bringing an oral, mutation-specific treatment option to a distinct patient population with substantial unmet need,” he added.
The medication is administered at a dose of 200 milligrams once daily with food.
ZEGFROVY has also been included in the National Comprehensive Cancer Network’s clinical practice guidelines for non-small cell lung cancer as a Category 2A recommended subsequent therapy option for patients with advanced or metastatic disease carrying EGFR exon 20 insertion mutations.
AstraZeneca is pursuing additional regulatory approvals that could expand the drug’s use to patients who have not previously received treatment.
The company has submitted supplemental applications to the FDA and China’s Center for Drug Evaluation seeking approval of ZEGFROVY as a first-line treatment. Those submissions are supported by results from the Phase 3 WU-KONG28 clinical trial.
Regulators in both countries have granted Breakthrough Therapy Designation to the drug for the proposed first-line indication.
Despite its potential benefits, ZEGFROVY carries risks of serious adverse reactions, including potentially life-threatening interstitial lung disease or pneumonitis, severe gastrointestinal complications, skin reactions and eye toxicity.
The treatment can also cause fetal harm if administered during pregnancy.
ZEGFROVY is available in the United States through the company’s specialty distribution and pharmacy network. Health systems may also obtain the medication through their own specialty pharmacies.
The launch strengthens AstraZeneca’s position in precision oncology, where treatments are increasingly developed to target specific genetic mutations responsible for cancer growth.
