ILCN Lung Cancer News
ILCN Lung Cancer News

Regulatory Agency Perspective


  • In Brief for November 13, 2024

    In Brief for November 13, 2024

    Haleigh Behrman
    Regulatory Agency Perspective

    US FDA approves TTFields therapy as a treatment for mNSCLC.


  • In Brief for October 23, 2024

    In Brief for October 23, 2024

    Haleigh Behrman
    Regulatory Agency Perspective

    Pembrolizumab, amivantamab-vmjw, osimertinib, and nivolumab join the list of FDA-approved treatments for various lung cancer indications.


  • US FDA Announces Multiple Moves with Implications for Lung Cancer Care

    US FDA Announces Multiple Moves with Implications for Lung Cancer Care

    Erin Jungmeyer
    Regulatory Agency Perspective

    At the end of 2023, the agency approved repotrectinib for ROS1+ NSCLC, granted priority review for tarlatamab for advanced SCLC, and asked for an additional confirmatory trial for sotorasib for KRAS G12C-mutated NSCLC.


  • In Brief for Dec. 21, 2022

    In Brief for Dec. 21, 2022

    Erin Jungmeyer
    Regulatory Agency Perspective, Society News

    IASLC names J. Michael Hoehn COO. FDA approves adagrasib for KRAS G12C-mutated NSCLC. NHS England increases access to screening in effort to catch cancers earlier.


  • In Brief for Dec. 7, 2022

    In Brief for Dec. 7, 2022

    Erin Jungmeyer
    Meeting News, Regulatory Agency Perspective

    Learn how new guidance from the UK’s National Institutes for Health Care Excellence addresses an unmet clinical need for patients with EGFR+ NSCLC with exon 20 insertion and stay up to date on the latest meeting news from IASLC.


  • Pembrolizumab Considered for Second Tissue-Agnostic Cancer Indication

    Pembrolizumab Considered for Second Tissue-Agnostic Cancer Indication

    Regulatory Agency Perspective

    By Erik MacLaren, PhD Posted: August 21, 2020 The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Merck’s immune checkpoint inhibitor pembrolizumab, adding a new tissue-agnostic indication for patients, including children, who have solid tumors with a tumor mutational burden (TMB) of 10 or more mutations per megabase of DNA.1 The new…


  • New FDA Commissioner Confirmed

    New FDA Commissioner Confirmed

    Regulatory Agency Perspective

    Posted: February 12, 2020 December 12, 2019—Stephen M. Hahn, MD, FASTRO, was confirmed as commissioner of the U.S. Food and Drug Administration by a Senate vote of 72 to 18. Dr. Hahn will vacate his current position as chief executive officer of The University of Texas MD Anderson Cancer Center, which he has held since…


  • Dr. Richard Pazdur Discusses Project Facilitate and the Expanded-Access Program

    Dr. Richard Pazdur Discusses Project Facilitate and the Expanded-Access Program

    Regulatory Agency Perspective

    Posted: December 11, 2019 In June 2019, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence launched Project Facilitate, a call center that assists oncology healthcare professionals with the submission process involved in obtaining unapproved therapies for individual patients with cancer via the Expanded Access program.1 Richard Pazdur, MD, director of the FDA…


  • NCI Director Dr. Norman E. Sharpless Discusses 2019 Budget Plans During Social Media Event

    NCI Director Dr. Norman E. Sharpless Discusses 2019 Budget Plans During Social Media Event

    Regulatory Agency Perspective

    By Erik MacLaren, PhD Posted: April 1, 2019 On January 25, 2019, the Director of the National Cancer Institute (NCI) Norman E. Sharpless, MD, participated in a live social media event to discuss the NCI’s budget plans for 2019. During the hour-long discussion, Dr. Sharpless presented his assessment of the current funding situation, elaborated on his…


  • FDA Approval Processes in the Era of Targeted Therapies: A Conversation with Dr. Richard Pazdur

    FDA Approval Processes in the Era of Targeted Therapies: A Conversation with Dr. Richard Pazdur

    Regulatory Agency Perspective

    Posted: December 2018 Richard Pazdur, MD, is director of the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence. Below, he discusses the current status of and future directions for the FDA’s approval of oncology drugs. Q: Has the accelerated conditional approval process been a success in your view? Are there aspects you would…