ILCN Lung Cancer News
ILCN Lung Cancer News


  • FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

    FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

    Industry News & Regulatory Approvals

    The US Food and Drug Administration (FDA) granted Accelerated Approval to pralsetinib as treatment for adults with metastatic NSCLC who harbor RET fusions. The first and only test to identify RET fusion–positive NSCLC, the Oncomine Dx Target Test, was granted premarket approval as a companion diagnostic for pralsetinib therapy. The test will be updated to report RET fusions by early 2021 in the United States. Pralsetinib’s approval…


  • 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…


  • FDA Corner – Interview with Gideon Blumenthal, MD

    FDA Corner – Interview with Gideon Blumenthal, MD

    Regulatory Agency Perspective

    By Erik J. Mac Laren, PhD In 2015, the US Food and Drug Administration (FDA) approved an unprecedented 7 new drugs or new uses for drugs for patients with lung cancer, an increase driven by the proliferation of targeted therapies in the area of thoracic oncology. The advent of precision medicine in oncology has raised…