Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb recently joined ASCO CEO Dr. Clifford A. Hudis on the ASCO in Action Podcast to discuss FDA efforts to modernize clinical trials, improve the expanded access program, reduce drug prices, and expedite the drug development process. Dr. Gottlieb also addressed tobacco control, including the alarming uptick in youth e-cigarette use in the United States and the actions FDA is taking to combat the issue.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
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President Trump signed into law a funding bill that provides FDA with $3.08 billion in government funding for fiscal year 2019 – a $269 million increase, and the largest boost to FDA in at least five years.
On February 15, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
On February 12, 2019, ASCO leadership and members of the society’s Government Relations Committee met with representatives from key federal agencies, advisory groups, and other stakeholder organizations to discuss top cancer policy priorities. The meetings focused on access to clinical trials, drug pricing, step therapy, drug shortages, Medicaid waivers and other issues affecting people with cancer.
On February 6, 2019, the Food and Drug Administration approved caplacizumab-yhdp (CABLIVI®, Ablynx NV) for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
On January 14, 2019, the Food and Drug Administration approved cabozantinib (CABOMETYX®, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.