Sunvozertinib

November 2024 saw numerous FDA approvals, designations, and clinical trial advancements in oncology, including revumenib for KMT2A-rearranged acute leukemia, obe-cel for relapsed/refractory B-cell ALL, and fast track designations for ALE.P02 in Claudin-1-positive tumors. Other highlights include orphan drug designations for LBL-024 in neuroendocrine cancer and elraglusib in Ewing sarcoma, and a new drug application for sunvozertinib in EGFR-mutant NSCLC.

Dizal submitted sunvozertinib's NDA to the FDA for treating NSCLC with EGFR exon20ins mutations, supported by the WU-KONG1 Part B trial data. Sunvozertinib, an irreversible EGFR inhibitor, aims to improve outcomes for patients with EGFR exon20ins NSCLC.

OncLive’s weekly roundup highlights FDA approvals for obecabtagene autoleucel in R/R B-cell precursor ALL, sunvozertinib in pretreated EGFR exon 20+ advanced NSCLC, and updates to CLL/SLL NCCN guidelines. Interviews with experts discuss advancements in NSCLC and ongoing RAS inhibitor research in pancreatic cancer.

Dizal submitted an NDA to the FDA for sunvozertinib, an oral drug for NSCLC patients with EGFR exon20ins, after platinum-based chemotherapy. Sunvozertinib, already approved in China, received Breakthrough Therapy Designations from both the US FDA and China CDE. The submission is supported by the WU-KONG1 Part B study, showing significant ORR and manageable safety profile. Sunvozertinib targets a wide spectrum of EGFR mutations and demonstrated efficacy in various EGFR exon20ins subtypes and stable brain metastasis.

FDA NDA submitted for sunvozertinib (DZD9008; Dizal) in EGFR exon 20 insertion mutation–positive advanced NSCLC, post-platinum chemotherapy. Phase 2 WU-KONG1 trial data show 300 mg dose achieved 53.3% best ORR and 44.9% confirmed ORR. Median DOR not reached, with 9-month DOR rate at 57%. Safety consistent with prior studies; 6.3% discontinued treatment.

The FDA has received an NDA for sunvozertinib in relapsed/refractory NSCLC with EGFR exon 20 insertion mutations, supported by the phase 2 WU-KONG1 part B study. Data from the 2024 ASCO Annual Meeting showed a 54.3% ORR and 90.8% disease control rate. Sunvozertinib received breakthrough therapy designation in April 2024 and is already approved in China.

Sunvozertinib (DZD9008) NDA submitted to FDA for EGFR exon 20 insertion mutation–positive NSCLC, supported by WU-KONG1 trial data showing 53.3% best ORR and 44.9% confirmed ORR at 300 mg dose. Median DOR not reached, with 9-month DOR rate of 57%. Sunvozertinib already approved in China.

Dizal (Jiangsu) Pharmaceutical Co., Ltd. submitted a New Drug Application (NDA) to the U.S. FDA for sunvozertinib, seeking approval for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. Sunvozertinib, already approved in China, demonstrated significant objective response rate and manageable safety profile in the WU-KONG1 Part B study. Lung cancer, particularly NSCLC with EGFR exon20ins, has a poorer prognosis, and sunvozertinib, an irreversible EGFR inhibitor, aims to address this.

Dizal submitted an NDA to the FDA for sunvozertinib, the first oral drug for NSCLC patients with EGFR exon20ins, supported by the WU-KONG1 Part B study results presented at the 2024 ASCO Annual Meeting.

Dizal submits NDA to FDA for sunvozertinib, an oral drug for relapsed or refractory NSCLC with EGFR exon 20 insertion mutations, supported by WU-KONG1 Part B study data presented at 2024 ASCO Annual Meeting.