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


  • Regulatory Approval Brings New Targeted Treatment Option for NSCLC to European Union

    Regulatory Approval Brings New Targeted Treatment Option for NSCLC to European Union

    By

    Erin Jungmeyer
    Industry News & Regulatory Approvals

    The European Commission recently approved adagrasib for KRAS G12C+ non-small cell lung cancer. Additionally, the US FDA has accepted a premarket approval application for tumor treating fields therapy.


  • In Brief for November 8, 2023

    In Brief for November 8, 2023

    By

    Erin Jungmeyer
    Industry News & Regulatory Approvals

    October saw two approvals from the US FDA as well as caution from the agency’s Oncologic Drug Advisory Committee regarding the interpretation of CodeBreak 200 data; Takeda announces withdrawal of mobocertinib.


  • In Brief for June 28, 2023

    In Brief for June 28, 2023

    By

    Erin Jungmeyer
    Industry News & Regulatory Approvals

    Canada to require health warnings on cigarettes. US FDA approves application for pemetrexed injection, grants priority review for repotrectinib.


  • In Brief for May 24, 2023

    In Brief for May 24, 2023

    By

    Erin Jungmeyer
    Industry News & Regulatory Approvals, Meeting News

    Health Canada gives greenlight to cemiplimab-chemo combo for first-line treatment of advanced NSCLC. Early registration for WCLC 23 ends June 9.


  • In Brief for April 26, 2023

    In Brief for April 26, 2023

    By

    Erin Jungmeyer
    Industry News & Regulatory Approvals

    US Food and Drug Administration grants Fast Track designation for novel mesothelioma therapy.


  • Pragmatic Approach to Trial Design Born from Lung-MAP Substudy

    Pragmatic Approach to Trial Design Born from Lung-MAP Substudy

    By

    Erin Jungmeyer
    Evolving Standards of Care, Industry News & Regulatory Approvals

    In a recent interview with ILCN, the US FDA’s Dr. Harpreet Singh discusses the confirmatory Pragmatica-Lung trial and how the agency’s new pragmatic approach to trial design can streamline research and ultimately benefit patients.


  • Narrow Focus Allows Pragmatica-Lung Trial to Minimize Eligibility Criteria, Significantly Reduce Data Collection, Researcher Says

    Narrow Focus Allows Pragmatica-Lung Trial to Minimize Eligibility Criteria, Significantly Reduce Data Collection, Researcher Says

    By

    Erin Jungmeyer
    Evolving Standards of Care, Industry News & Regulatory Approvals

    In a recent interview with ILCN, Dr. Karen Reckamp discussed the overall survival implications from the phase II Lung-MAP study and how the phase III follow-up Pragmatica-Lung trial aims to confirm that specific endpoint.


  • In Brief for Feb. 8, 2023

    In Brief for Feb. 8, 2023

    By

    John Austin
    Industry News & Regulatory Approvals, Names & News

    Dr. Carolyn Dresler Joins Action on Smoking and Health (ASH) Board of Trustees; Novel Liquid Biopsy Assay for Lung Carcinoma Detection Receives FDA Breakthrough Device Designation.


  • In Brief for January 25, 2023

    In Brief for January 25, 2023

    By

    John Austin
    Industry News & Regulatory Approvals, Society News

    China approves mobocertinib for patients with EGFR Exon20 insertion+ NSCLC; Deadline approaching for IASLC 2023 Lectureship and Distinguished Service Award Nominations.


  • In Brief for Jan. 11, 2023

    In Brief for Jan. 11, 2023

    By

    John Austin
    Industry News & Regulatory Approvals

    Japan greenlights durvalumab and tremelimumab in combination with chemotherapy; US approves companion diagnostic tool for certain TKIs and expands indications for pemetrexed injection.