FDA grants priority review to oral non-small cell lung cancer drug

The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with locally advanced or metastatic non-small cell lung cancer, according to a press release from Dizal.

The application applies to individuals with tumors that harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) identified by an FDA-approved test, the release states.

“Patients with EGFR exon20ins [non-small cell lung cancer (NSCLC)] face a poor prognosis and limited treatment options,” Xiaolin Zhang, PhD, CEO of Dizal, said in the release. “Sunvozertinib’s priority review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide.”

According to the release, sunvozertinib inhibits EGFR and is specifically for patients with the outlined disease who have received platinum-based chemotherapy but experienced disease progression.

The FDA based this decision, in part, on data from the WU-KONG1 Part B study that included patients from four continents: Asia, Europe, North America and South America. The release stated that the drug “demonstrated statistically significant clinical benefits” in patients with relapsed/refractory NSCLC with EGFR exon20ins.

“The results from the WU-KONG1 Part B study are promising,” Zhang said in the release. “If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins.”

The release did not provide a Prescription Drug User Fee Act target date.