The American Journal of Managed Care

FDA Approves Sunvozertinib in Non–Small Cell Lung Cancer

Sunvozertinib is the first targeted oral treatment for NSCLC with EGFR exon 20 insertion mutations, approved for post-chemotherapy progression cases. The WU-KONG1 Part B study showed a 53.3% objective ...
The American Journal of Managed Care

Sunvozertinib NDA Submitted to FDA for NSCLC

Sunvozertinib shows promise for NSCLC with EGFR exon 20 insertion mutations, achieving a 53.3% ORR in the WU-KONG1 trial. The FDA application is supported by phase 2 trial data, with a focus on ORR ...
Mena FN

Sunvozertinib Granted Breakthrough Therapy Designation By China CDE For The First-Line Treatment Of Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

SHANGHAI, Oct. 13, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that ...
MedPage Today

Novel TKI, Sunvozertinib, in Platinum-Pretreated NSCLC Patients With Exon 20 Insertion Mutations

Exon 20 insertion mutations in non-small cell lung cancers have been a therapeutic challenge, and thus new agents targeting exon 20 mutations are a welcome addition. The study by James Chih-Hsin Yang ...
Medscape

Sunvozertinib Wins Approval for EGFR-Mutated NSCLC

The FDA has granted accelerated approval to sunvozertinib (Zegfrovy, Dizal Pharmaceutical) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor ( ...
ascopubs.org

Sunvozertinib for the treatment of NSCLC with EGFR Exon20 insertion mutations: The first pivotal study results.

Randomized phase 3 study of first-line AZD3759 (zorifertinib) versus gefitinib or erlotinib in EGFR-mutant (EGFRm+) non–small-cell lung cancer (NSCLC) with central nervous system (CNS) metastasis.
Cure Today

FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC

Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...
Yahoo Finance

Dizal Completes Enrollment for its Phase III Pivotal Study of Sunvozertinib vs. Platinum Doublet in Treatment Naïve NSCLC Patients with EGFR Exon20 Insertional Mutations

SHANGHAI, June 19, 2025 /PRNewswire/ -- Dizal announced the completion of patient enrollment for its WU-KONG28 clinical trial: a multinational, randomized phase III study evaluating the efficacy and ...
Yahoo Finance

U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug Application

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 Sunvozertinib's NDA was submitted ...
Pharmabiz

Dizal announces positive pooled data of sunvozertinib in EGFR TKI-resistant NSCLC

Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the publication of a pooled analysis evaluating ...
ascopubs.org

Antitumor activity of sunvozertinib in NSCLC patients with EGFR Exon20 insertion mutations after platinum and anti-PD(L)1 treatment failures.

Osimertinib plus necitumumab in EGFR-mutant NSCLC: Final results from an ETCTN California Cancer Consortium phase I study. This is an ASCO Meeting Abstract from the 2022 ASCO Annual Meeting I. This ...
scmp.com

‘Breakthrough therapy’: a new Chinese drug shows record treatment success against one of the deadliest lung cancers

For patients wrestling with an uncommon and recalcitrant subtype of lung cancer that will not ease with conventional therapies, such as platinum-based chemotherapy, a Chinese targeted antitumour drug ...