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


  • In Brief for February 26, 2025

    In Brief for February 26, 2025

    By

    Haleigh Behrman
    Evolving Standards of Care, Global Initiatives, Industry News & Regulatory Approvals

    Durvalumab is recommended for approval in the EU, Health Canada approves pembrolizumab, and the US FDA grants priority review to datopotamab deruxtecan.


  • New Combination Therapies Mean More Options, Challenge Decision-Making

    New Combination Therapies Mean More Options, Challenge Decision-Making

    By

    Haleigh Behrman
    Evolving Standards of Care, Industry News & Regulatory Approvals, Society News

    Dr. Susan Scott discusses how findings from the MARIPOSA and FLAURA-2 trials will be incorporated into clinical practice.


  • In Brief for February 12, 2025

    In Brief for February 12, 2025

    By

    Haleigh Behrman
    Global Initiatives, Industry News & Regulatory Approvals

    The US FDA grants fast track designation to treat KRAS G12C-mutant metastatic NSCLC and China’s NMPA approves taletrectinib for advanced ROS1-positive NSCLC.


  • In Brief for January 22, 2025

    In Brief for January 22, 2025

    By

    Haleigh Behrman
    Global Initiatives, Industry News & Regulatory Approvals, Society News

    FDA issues draft guidance on the use of AI for biological and drug product submissions, China’s NMPA grants priority review for the combination of savolitinib and osimertinib, and nivolumab and hyaluronidase-nvhy receive FDA approval for subcutaneous injection.


  • In Brief for January 8, 2025

    In Brief for January 8, 2025

    By

    Haleigh Behrman
    Industry News & Regulatory Approvals

    The US FDA approves ensartinib for ALK-positive NSCLC and provides an updated regulatory review of subcutaneous amivantamab.


  • In Brief for December 18, 2024

    In Brief for December 18, 2024

    By

    Haleigh Behrman
    Industry News & Regulatory Approvals

    European Medicines Agency recommends repotrectinib for ROS1-positive NSCLC; FDA approves therapies for NSCLC, LS-SCLC as well as a new diagnostic tool for identifying MET exon 14 skipping alterations.


  • In Brief for October 9, 2024

    In Brief for October 9, 2024

    By

    Haleigh Behrman
    Industry News & Regulatory Approvals

    US FDA greenlights subcutaneous atezolizumab, grants Breakthrough Therapy Designation for novel antibody drug conjugate to treat SCLC.


  • In Brief for September 25, 2024

    In Brief for September 25, 2024

    By

    Haleigh Behrman
    Industry News & Regulatory Approvals

    Fulzerasib becomes the first KRAS G12C inhibitor approved in China. Encorafenib receives approval from the European Commission. The US FDA grants priority review and breakthrough therapy designation to durvalumab for SCLC.


  • FLAURA-2 Results Lead to Approval of Osimertinib Plus Chemotherapy in European Union, Japan

    FLAURA-2 Results Lead to Approval of Osimertinib Plus Chemotherapy in European Union, Japan

    By

    Erin Jungmeyer
    Industry News & Regulatory Approvals

    In other recent regulatory news, Health Canada authorized amivantamab in combination with carboplatin and pemetrexed for patients with non-small cell lung cancer with EGFR Exon 20 insertion mutations.


  • Recently Reported Evidence Leads to Approvals for Alectinib, Osimertinib

    Recently Reported Evidence Leads to Approvals for Alectinib, Osimertinib

    By

    Erin Jungmeyer
    Industry News & Regulatory Approvals

    The European Commission has approved adjuvant alectinib for ALK+ early-stage NSCLC while the US FDA has granted priority review for osimertinib for unresectable stage III EGFR+ NSCLC.