Timely and relevant thoracic oncology news brought to you by the only global association dedicated to the multidisciplinary study of lung cancer.

Timely and relevant thoracic oncology news brought to you by the only global association dedicated to the multidisciplinary study of lung cancer.


Industry News & Regulatory Approvals


  • Investigational KRAS G12D Agents Demonstrate Promising Antitumor Activity in Non-Small Cell Lung Cancer

    Investigational KRAS G12D Agents Demonstrate Promising Antitumor Activity in Non-Small Cell Lung Cancer

    By

    Taylor Fithian
    Evolving Standards of Care, Industry News & Regulatory Approvals

    Early findings from two clinical studies support the continued development of setidegrasib and zoldonrasib to target KRAS G12D mutations.


  • Inhaled Gene Therapy Receives FDA RMAT Designation for Advanced NSCLC

    Inhaled Gene Therapy Receives FDA RMAT Designation for Advanced NSCLC

    By

    Taylor Fithian
    Industry News & Regulatory Approvals

    The decision was based on findings from the KYANITE-1 trial, which demonstrated that the treatment was generally well tolerated with single-agent antitumor activity observed.


  • Zongertinib Receives FDA Accelerated Approval for HER2-Mutant NSCLC

    Zongertinib Receives FDA Accelerated Approval for HER2-Mutant NSCLC

    By

    Taylor Fithian
    Industry News & Regulatory Approvals

    The decision marks the second approval granted under a new national priority pilot program designed to expedite the review process for drugs that are eligible for priority review.


  • In Brief for January 14, 2026

    In Brief for January 14, 2026

    By

    Taylor Fithian
    Industry News & Regulatory Approvals

    The US FDA grants special designation to risvutatug rezetecan for SCLC and approves the subcutaneous formulation of amivantamab plus hyaluronidase-lpuj for EGFR+ NSCLC.


  • In Brief for December 3, 2025

    In Brief for December 3, 2025

    By

    Taylor Fithian
    Industry News & Regulatory Approvals, Society News

    The US FDA has granted two separate approvals: one to sevabertinib for non-squamous NSCLC and another to tarlatamab-dlle for ES-SCLC.


  • In Brief for November 19, 2025

    In Brief for November 19, 2025

    By

    Taylor Fithian
    Evolving Standards of Care, Industry News & Regulatory Approvals

    The US FDA confirms the use of pembrolizumab and berahyaluronidase alfa-pmph as an injectable therapy for solid tumor indications.


  • In Brief for November 5, 2025

    In Brief for November 5, 2025

    By

    Taylor Fithian
    Industry News & Regulatory Approvals, Society News

    FDA clears a combination medication for extensive-stage small cell lung cancer for patients whose disease has not progressed after first-line induction therapy.


  • In Brief: July 23, 2025

    In Brief: July 23, 2025

    By

    Haleigh Behrman
    Industry News & Regulatory Approvals, Society News

    The US FDA grants Orphan Drug Designation to CID-078 for SCLC, and zidesamtinib demonstrates positive early data in ROS1-positive NSCLC.


  • In Brief for July 9, 2025

    In Brief for July 9, 2025

    By

    Haleigh Behrman
    Industry News & Regulatory Approvals, Society News

    The FDA grants accelerated approval to Dato-DXd, while a Biologics License Application for HER3-DXd is voluntarily withdrawn.


  • Research to Watch: FDA Grants ZL-1310 Fast Track Designation for Extensive-Stage SCLC

    Research to Watch: FDA Grants ZL-1310 Fast Track Designation for Extensive-Stage SCLC

    By

    Haleigh Behrman
    Industry News & Regulatory Approvals, Society News

    ZL-1310 earns Fast Track Designation as a potential first-in-class DLL3-targeted ADC for extensive-stage small cell lung cancer.