ILCN Lung Cancer News
ILCN Lung Cancer News

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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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.