The US Food and Drug Administration (FDA) has granted accelerated approval to Dizal’s Zegfrovy (sunvozertinib) to treat a subset of non-small cell lung cancer (NSCLC) patients.
The drug has been authorised to treat locally advanced or metastatic NSCLC in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) whose disease has progressed on or after platinum-based chemotherapy.
The American Cancer Society estimates that approximately 226,650 people will be diagnosed with lung cancer in the US this year, with NSCLC accounting for around 87% of all cases.
EGFR is involved in the growth and division of healthy cells. However, a mutation in the gene coding for EGFR can lead to the protein being significantly over-expressed, causing cells to grow out of control, which can lead to cancer.
The FDA’s decision on Zegfrovy, which makes it the only targeted oral treatment approved in the US for EGFR exon20in NSCLC, was supported by results from the pivotal WU-KONG1 part B study.
Data presented at last year’s American Society of Clinical Oncology (ASCO) annual meeting showed that Zegfrovy achieved an objective response rate of 53.3%, and a nine-month duration of response of 57%.
Anti-tumour efficacy was observed regardless of amivantamab treatment, and Dizal’s drug was well tolerated with a favorable safety profile.
The company’s chief executive officer, Xiaolin Zhang, said: “We are proud to have developed Zegfrovy, a first-in-class oral therapy that offers a more effective treatment option with enhanced safety and ease of administration for NSCLC patients with EGFR exon20ins.”
Lead principal investigator of WU-KONG1B, Pasi Jänne, added that the approval “marks a landmark in scientific advancement and represents a meaningful milestone in addressing the long-standing unmet medical needs of this underserved patient population”.
In line with the FDA’s accelerated approvals pathway, continued approval for Zegfrovy in this indication may be contingent on the verification of clinical benefit in a confirmatory trial.
Alongside its authorisation of Zegfrovy, the FDA approved Thermo Fisher Scientific’s Oncomine Dx Express Test to identify patients eligible for Dial’s drug.