US EditionWith FDA Nod in Lung Cancer, Dizal Now Aims to Best a J&J Drug and Succeed Where Takeda Fell Short
UNITED STATES, JUL 2 – Zegfrovy achieved a 46% confirmed overall response rate and an 11.1-month median duration of response in patients with EGFR exon 20 insertion NSCLC after chemotherapy failure, FDA said.
- In early 2025, the US Food and Drug Administration granted accelerated approval to sunvozertinib for EGFR exon 20 insertion NSCLC, alongside approval of the Oncomine Dx Express Test.
- Patients with EGFR exon 20 insertion mutations resist current EGFR inhibitors and often progress after platinum chemotherapy, prompting FDA approval of sunvozertinib as a targeted therapy.
- The WU-KONG1B trial showed a 46% overall response rate and 11.1-month response duration, assessed by blinded review per RECIST v1.1.
- Following FDA approval, Zegfrovy becomes the only targeted oral NSCLC therapy for EGFR exon 20 insertions, but its US launch timing and marketing plans remain uncertain.
- Beyond this approval, Dizal is conducting multiple trials, including the WU-KONG28 Phase III study across 16 countries, to expand sunvozertinib's use in various NSCLC settings.
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64 Articles
With FDA Nod in Lung Cancer, Dizal Now Aims to Best a J&J Drug and Succeed Where Takeda Fell Short
Dizal Pharmaceutical’s Zegfrovy is now FDA approved for treating non-small cell lung cancer driven by a particular rare genetic signature. Johnson & Johnson drug Rybrevant already addresses this genetic signature as an earlier line of therapy, but Dizal executives contend their drug offers the potential for better safety and efficacy. The post With FDA Nod in Lung Cancer, Dizal Now Aims to Best a J&J Drug and Succeed Where Takeda Fell Short appe…
LoudounTimes.com
Dizal's ZEGFROVY® (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20insApproval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which ZEGFROVY demonstrated statistically significant and clinically meaningful benefits to…
FDA approves new lung cancer pill - Juta MedicalBrief
The US Food and Drug Administration (FDA) has granted accelerated approval to a first-of-its-kind pill for non-small-cell lung cancer (NSCLC). The medication, called sunvozertinib and sold as Zegfrovy, is for adults with advanced NSCLC, and works for those whose cancer has a certain genetic change, called an EGFR exon 20 insertion mutation. The drug is used when the cancer has worsened during or after chemotherapy. It is taken orally once a day,…
FDA grants accelerated approval for advanced non-small cell lung cancer treatment - Pharmafile
The US Food and Drug Administration (FDA) has granted accelerated approval to Dizal Therapeutic’s Zegfrovy (sunvozertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR exon 20 insertion mutations. This covers patients whose disease has progressed following platinum-based chemotherapy. Alongside the drug approval, the FDA approved the […] The post FDA grants accelerated approva…
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