ASCO has submitted joint responses with the American Association for Cancer Research (AACR) to three Advance Notices of Proposed Rulemaking (ANPRM) issued by the Food and Drug Administration (FDA) related to tobacco regulation. The comment letters responded to setting a nicotine level standard, using flavors in tobacco products, and regulating cigars.
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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ASCO submitted a statement to the U.S. House of Representatives Energy and Commerce Committee in conjunction with a subcommittee hearing on implementation of the Merit-Based Incentive Payment System (MIPS) under the Medicare Access and CHIP Reauthorization Act (MACRA).
ASCO has been notified that Takeda Oncology was recently advised by the U.S. Food and Drug Administration that the Risk Evaluation and Mitigation Strategy communication plan for ICLUSIG® (ponatinib) is no longer required.
On July 31, 2018, the Food and Drug Administration approved lusutrombopag (Mulpleta®, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
On July 30, 2018, the Food and Drug Administration approved iobenguane I 131 (AZEDRA®, Progenics Pharmaceuticals, Inc.) for adult and pediatric patients (12 years and older) with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.
On July 25, the U.S. House Energy and Commerce Committee held a hearing during which Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, Director of the National Cancer Institute (NCI) Norman Sharpless, MD, and Director of National Institutes of Health Francis Collins, MD, PhD, provided updates on how their respective agencies have been implementing the 21st Century Cures legislation.
On July 25, the Centers for Medicare & Medicaid Services released its 2019 Hospital Outpatient Prospective Payment System proposed rule. Among other provisions, the proposal would extend 2018 reimbursement cuts to the 340B Drug Pricing Program to include currently excepted, off-site hospital-affiliated outpatient clinics.
A new “frailty index” predicts overall survival for patients newly diagnosed with multiple myeloma, according to a study published on July 25 in JCO Clinical Cancer Informatics.
In a new ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis highlights the newly launched ASCO campaign, I Live to Conquer Cancer, and discusses how ASCO members and the cancer care community can get involved.
On July 20, 2018, the Food and Drug Administration approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
On July 18, 2018, the Food and Drug Administration expanded the indication for ribociclib (Kisqali®, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
ASCO submitted a response to the Request for Information (RFI) that was included in the Trump Administration's “blueprint to lower drug prices and reduce out-of-pocket costs.” In a letter to Secretary of the U.S. Department Health and Human Services (HHS) Alex Azar, ASCO recommends a value-based approach to address rising drug costs and makes specific recommendations regarding the 340B Drug Pricing Program, reviving the Competitive Acquisition Program (CAP), moving drugs from Medicare Part B to Part D, and site neutrality proposals.
"I Live to Conquer Cancer" is a new national outreach and awareness initiative that builds on ASCO’s continued advocacy activities in support of the National Institutes of Health (NIH) and the National Cancer Institute (NCI), and aims to underscore the critical importance of federally funded cancer research.
On July 13, 2018, the Food and Drug Administration approved enzalutamide (XTANDI®, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).
ASCO’s Policy Issue Briefs provide succinct overviews and relevant data on major policy issues impacting patients with cancer and the physicians who care for them. These briefs are designed to be especially helpful for journalists, offering background information on key issues across health policy today.