Sunvozertinib

Dizal submitted an NDA to the FDA for sunvozertinib, seeking approval for treating advanced NSCLC with EGFR exon20ins, supported by the WU-KONG1 study results.

Dizal received its fourth Breakthrough Therapy Designation (BTD) for sunvozertinib from China's CDE for first-line treatment of EGFR exon20ins NSCLC, following US FDA's BTD in April. Sunvozertinib showed 78.6% cORR and 12.4 months mPFS in phase I/II studies, with ongoing phase III WU-KONG28 study comparing it to platinum doublet chemotherapies. Sunvozertinib is the first oral drug approved for EGFR exon20ins NSCLC in China, with ongoing regulatory submissions globally.

Sunvozertinib (DZD9008) received breakthrough therapy designation from China’s CDE for first-line treatment of EGFR exon 20 insertion mutation–positive NSCLC, supported by WU-KONG1 and WU-KONG15 study results. At 10.8 months follow-up, treatment-naive patients showed 78.6% cORR and 12.4 months median PFS with 300 mg dose. Sunvozertinib was also approved by NMPA for advanced EGFR exon 20–mutant NSCLC progressing after platinum-based chemotherapy. A phase 3 WU-KONG28 study is ongoing to compare sunvozertinib with platinum doublet chemotherapy in treatment-naive EGFR exon 20–mutant NSCLC patients.

Dizal receives fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins, reflecting its transformative potential and Dizal's commitment to developing new treatments for unmet medical needs globally.

Dizal receives fourth Breakthrough Therapy Designation for sunvozertinib in EGFR exon20ins NSCLC, following U.S. FDA approval in April. The designation aims to expedite development and review of new treatments for serious conditions, with sunvozertinib showing a 78.6% confirmed objective response rate and 12.4 months median progression-free survival in treatment-naïve patients.

NMPA approves LungCure CDx, a NGS-based companion diagnostic, to guide sunvozertinib use in EGFR exon 20 insertion mutation–positive NSCLC. This marks the first NMPA approval of a co-developed NGS-based companion diagnostic in China. LungCure CDx detects EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET mutations in NSCLC, aiding targeted therapy selection. Sunvozertinib received NMPA approval for advanced NSCLC with EGFR exon 20 insertion mutations, supported by phase 2 WO-KONH6 trial results. The drug also holds FDA breakthrough therapy designations for relapsed/refractory and frontline NSCLC with EGFR exon 20 insertion mutations.

Burning Rock Biotech and Dizal announce NMPA approval of their co-developed NGS-based CDx for EGFR exon20ins in lung cancer, marking the first such approval since China's CDx guideline release.