Dizal’s Phase III NSCLC trial of Zegfrovy meets primary endpoint

The open-label trial enrolled patients across 16 countries and regions in Europe, Asia, South America, and North America.
CURE

Zegfrovy Delays Cancer Growth vs Chemotherapy in Some Lung Cancers

Sunvozertinib achieved a statistically significant, clinically meaningful PFS advantage over platinum-based chemotherapy by ...
pharmaphorum

Dizal breaks new ground for EGFR drugs in lung cancer

Dizal Pharmaceutical's Zegfrovy has taken the EGFR inhibitor class into new territory after hitting the mark in a phase 3 trial as a first-line treatment for non-small cell lung cancer (NSCLC) with ...

ArriVent to Present Two Preclinical Posters on the EGFR Inhibitor Firmonertinib and on the Novel dual-target MUC16/NaPi2b Tetravalent ADC ARR-002 at the 2026 AACR Annual Meeting

Unique structural features of firmonertinib enhance binding and activity against EGFR mutant proteins including ex20ins mutant proteins in cell ...
ascopubs.org

Comprehensive Genomic Analysis of Patients With Non–Small-Cell Lung Cancer Using Blood-Based Circulating Tumor DNA Assay: Findings From the BFAST Database of a Single Center ...

Pan-Cancer Interrogation of MUTYH Variants Reveals Biallelic Inactivation and Defective Base Excision Repair Across a Spectrum of Solid Tumors Clinically relevant actionable mutations were identified ...
The American Journal of Managed Care

Current and Emerging Options for Uncommon EGFR- and Exon 20 Insertion–Mutated NSCLC

Uncommon EGFR mutations, such as exon 20 insertions, account for nearly one-third of EGFR-driven NSCLC, complicating treatment strategies due to their diversity and structural challenges. Traditional ...
WebMD

FDA OKs First-of-Its-Kind Lung Cancer Pill

July 7, 2025 – The FDA has granted quick approval to a first-of-its-kind pill for a type of lung cancer known as non-small-cell lung cancer (NSCLC). The drug, called sunvozertinib and sold as Zegfrovy ...
clinicaladvisor.com

FDA Greenlights Oral Therapy for NSCLC With EGFR Exon20 Insertion Mutations

In a primary efficacy population of 85 patients, the confirmed overall response rate was 46%. The Food and Drug Administration (FDA) has granted accelerated approval to Zegfrovy ® (sunvozertinib) for ...
The American Journal of Managed Care

Takeda to Voluntarily Withdraw Mobocertinib for EGFR Exon 20 Insertion+ NSCLC

Following discussions with FDA, Takeda will voluntarily withdraw mobocertinib in the United States for adult patients with EGFR exon 20 insertion mutation–positive, locally advanced or metastatic ...
ascopubs.org

Enhanced detection and characterization of targetable EGFR and ERBB2 exon20 insertion mutations in urothelial carcinoma.

Phase 1b/2 dose expansion, open-label study to evaluate safety and anti-tumor activity of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer. This is an ...
Nasdaq

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR ...

Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone ...
GEN - Genetic Engineering and Biotechnology News

Safer Large DNA Insertion Moves Genetic Medicine Toward Scalability

INSTALL results showed successful and safe non-viral insertion of large genetic payloads in the livers of mice when delivered by lipid nanoparticles (LNPs). In contrast, mice experienced fatal immune ...