Sunvozertinib, first line, EGFR exon 20 insertion NSCLC
First-line use of sunvozertinib in EGFR exon 20 insertion mutation-positive NSCLC: the trial readout, its publication, regulatory filings and designations, and the guideline position, each as the institution or its recorder stated it.
| Date | Institution | What was recorded | Source | Digest |
|---|---|---|---|---|
| China NMPA, Center for Drug Evaluation — as recorded by the sponsor | Dizal release: the CDE “has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY® (sunvozertinib)” in EGFR exon 20 insertion mutation-positive NSCLC, headlined as first-line treatment and “based on the results of WU-KONG28 study”. | SRC-004 retrieved 2026-07-31 | sha256 6dc5663822dd9950c749c765045abe4c3ce4d8f6f632251106d222c577549214 chain 4608f395d1668ed46c9541b81e4f8f629f99b3190477c4906c0782d686c7d650 | |
| Dizal (sponsor) | Dizal announces WU-KONG28 phase 3 results. The release headlines that sunvozertinib “outperforms platinum-doublet chemotherapy” in first-line EGFR exon 20 insertion mutation-positive NSCLC, “presented as a Late-Breaking Abstract Oral Presentation (#LBA8500)” at ASCO 2026 “and simultaneously published in The New England Journal of Medicine”. | SRC-001 retrieved 2026-07-31 | sha256 8d36a5ba14efa04cbdbbc0ea3ceda931828048f5dfdeed0c9621ed5fdd394489 chain 49a03be772ed184d1a6834b43f5414a86dbe30a91ef277ee72c2d60e3e8ab323 | |
| The New England Journal of Medicine — PubMed record | Primary publication indexed: “First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations”, N Engl J Med, PMID 42212913, doi 10.1056/NEJMoa2604461. Archived as the PubMed record because the publisher served a bot-challenge page rather than the article. | SRC-002 retrieved 2026-07-31 | sha256 a8b05e1e6f2c03013cad238c9404d0f10d28437e26d60251c01d55052a61a6fe chain 0ee99e5f59acb815f375816bb7c28bfd0149b16afcfeb06434a7a185dcdcc94c |
All 8 rows, the chain scheme, and the steps to recompute it
Observation only: dated, sourced, and hash-chained. Phase 0, 2026-09-06.