An NDA has been submitted by Dizal Pharma to the FDA for approval of sunvozertinib (DZD9008) for locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 2.
A new drug application (NDA) has been submitted to the FDA seeking the approval of sunvozertinib (DZD9008) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
The NDA is supported by data from part B of the phase II WU-KONG1 trial (NCT03974022), which were presented at the 2024 ASCO Annual Meeting. Findings showed that patients treated with sunvozertinib at a 300-mg dose (n = 107) achieved a best overall response rate (ORR) of 53.3% (97.5% CI, 42.0%-64.3%) and a confirmed ORR of 44.9% (97.5% CI, 34.0%-56.1%). Best responses comprised complete response (CR; 2.8%), confirmed CR (1.9%), partial response (PR; 50.5%), confirmed PR (43.0%), unconfirmed PR (3.7%), stable disease (36.4%), and progressive disease (7.5%). Response was not evaluable in 2.8% of patients.The median duration of response (DOR) was not reached, and the 9-month DOR rate was 57%. Notably, the respective best ORRs for patients who received prior treatment with amivantamab-vmjw (Rybrevant) and those who did not were 50% and 53.8%.
“The filing for approval of sunvozertinib marks Dizal’s first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally."
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