On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin®, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. The FDA also accelerated approval to pembrolizumab (Keytruda®, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
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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During the American Medical Association (AMA) House of Delegates (HOD) annual meeting, delegates approved several ASCO-led resolutions and incorporated them into the AMA’s policy agenda.
Right-to-try is the latest topic addressed in the ASCO in Action podcast series. ASCO CEO Dr. Clifford Hudis recently interviewed ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky to examine RTT legislation—now enacted as federal law—and discuss the Food and Drug Administration’s (FDA) expanded access program.
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda®, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
From June 9 – 13, ASCO’s delegates will participate in the American Medical Association’s (AMA) Annual Meeting of the House of Delegates (HOD). The AMA HOD is the principal policy-making body of AMA, and meets twice a year to discuss pressing issues and establish association policies. ASCO currently sends three delegates to the AMA HOD: Edward P. Balaban, DO, FACP, FASCO; Thomas A. Marsland, MD, FASCO; and Ray D. Page, DO, PhD, FACOI.
Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have been developed and marketed as competitive, lower-cost alternatives to newer biologic treatments. This pathway was established to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. Biosimilars are among the fastest-growing class of drugs in the United States, a class called biological products.
On May 15, ASCO submitted comments to Congressional committees applauding their commitment to addressing the opioid crisis but urged them to ensure that such efforts do not prevent patients with cancer from receiving appropriate opioid therapy.
ASCO has been notified about a recent safety update relating to the drug BLINCYTO® (blinatumomab) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program.
In the newest ASCO in Action podcast, Dr. Gary H. Lyman, MPH, FASCO, FRCP, joins ASCO CEO Dr. Clifford A. Hudis to discuss biosimilars and ASCO’s recent statement on biosimilars published in the Journal of Clinical Oncology. Dr. Lyman is chair of the ASCO Biosimilars Work Group and lead author of the ASCO statement, which aims to educate cancer care providers on the use and regulation of biosimilars.
This ASCO in Action Brief is designed to help ASCO members gain a clearer understanding of the impact of state and federal right-to-try (RTT) legislation in the United States on oncology patients and practices.
National Prescription Drug Take Back Day—April 28, 2018— is a nationwide event to educate the public on the safe storage and disposal of drugs and to help patients safely, conveniently, and responsibly dispose of unused or expired opioids and other prescription medications throughout the year. On Take Back Day, patients can visit collection sites near them to turn in medications.
Last month, the Food and Drug Administration (FDA) held a listening session where stakeholders, including ASCO’s Chief Medical Officer, Richard L. Schilsky, MD, FACP, FSCT, FASCO, offered brief comments on role of the Oncology Center of Excellence (OCE).
Members of ASCO's Leadership Development Program held a Hill Day to advocate for federal research funding, oral parity, step therapy, and other cancer policy priorities.
ASCO submitted a budget request to a House Committee on Appropriations subcommittee, asking for $3.32 billion in funding for the Food and Drug Administration (FDA) and support for the Administration’s request of $20 million for FDA’s Oncology Center of Excellence (OCE) in Fiscal Year (FY) 2019.
In a letter to the Committee on Education and the Workforce Subcommittee on Health, Employment, Labor and Pensions leadership, ASCO and 25 other healthcare groups asked the House Subcommittee to consider the Restoring the Patients Voice Act of 2017 (H.R. 2077), which provides patient protections against step therapy protocols imposed by private sector health plans..