ILCN Lung Cancer News
ILCN Lung Cancer News

Regulatory Agency Perspective


  • NCI Corner – Interview with Dinah S. Singer, PHD

    NCI Corner – Interview with Dinah S. Singer, PHD

    Regulatory Agency Perspective

    By Erik J. MacLaren, PhD Blue Ribbon Panel of the US National Cancer Advisory BoardDuring his State of the Union address in January 2016, President Barack Obama announced a new effort led by Vice President Joe Biden to accelerate research into cancer, known as the Vice President’s Cancer Initiative, or the National Cancer Moonshot.1 Among…


  • Small Cell Lung Cancer: The Next Challenge

    Small Cell Lung Cancer: The Next Challenge

    Regulatory Agency Perspective

    By Peter Ujhazy, MD, PhD The newfound optimism in the management of lung cancer that infused the research, clinical, and patient communities 12 years ago is still gaining momentum. Seminal findings on the predictive value of epidermal growth factor receptor mutations1,2 were followed by discoveries of other therapeutic targets (ALK, ROS1, BRAF, etc.) and by…


  • Interview with Richard Pazdur, MD

    Interview with Richard Pazdur, MD

    Regulatory Agency Perspective

    New oncology drugs have, for decades, followed a well-trodden path of sequential clinical trials to get from the laboratory to the patient. This model has proven its worth by delivering effective new treatments while also protecting patient safety, but newer “seamless” trial designs have the potential to modernize the drug testing process and allow patients…


  • 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…


  • NCI Corner – Interview with Shakun Malik, MD

    NCI Corner – Interview with Shakun Malik, MD

    Regulatory Agency Perspective

    By Erik J. Mac Laren, PhD In late 2015, the US National Cancer Institute (NCI) Thoracic Malignancy Steering Committee (TMSC) published its strategic priorities for the coming years. These include: (1) innovative clinical trials to facilitate the development of immunotherapies and targeted therapies; (2) rapid testing of new agents to treat small cell lung cancer…