On Aug. 10, 2017, President Trump announced that the Administration is working on a plan to declare the opioid epidemic a “national emergency,” following recommendations put forward by the President’s Commission on Combating Drug Addiction and the Opioid Crisis on July 31.
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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On August 8, the FDA announced a new public health education campaign aimed at discouraging the use of e-cigarettes and electronic nicotine delivery systems (ENDS) by children. The program will include messaging towards teens about the dangers of these products and a full-scale campaign will be launched in 2018. This marks the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes.
On Aug. 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza®, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA™, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The August issue of the Journal of Oncology Practice (JOP) is a Special Series on ASCO’s 2017 Quality Care Symposium (QCS). The issue features research and highlights from this year’s meeting that brought together top leaders in the field to share strategies and methods for measuring and improving the quality and safety of cancer care.
The NCI released its bypass budget, proposing a $6.38 billion for the Institute in FY19 -- an increase of approximately 12% over NCI’s current FY 2017 budget. The proposed budget also includes $400 million in funding for the Cancer Moonshot Initiative.
On Aug. 3, the United States Senate approved a "right-to-try" bill by unanimous consent. The bill would authorize the use of unapproved drug therapies by terminally ill patients, who have exhausted other treatment options and are unable to participate in ongoing clinical trials, as long as the drugs have been tested in Phase I clinical trials and are continuing in further Food and Drug Administration (FDA) research. A physician must certify that the patient is not eligible for a clinical trial with the drug, but there no requirements for physician participation.
Did you miss any of ASCO’s webinar series on successful data reporting under the Quality Payment Program (QPP)? Would you like a refresher now that 2017 deadlines are approaching? If so, the entire webinar series is now available online to guide oncology practices to successful 2017 reporting under QPP and the Merit-Based Incentive Payment System.
The Senate passed the FDA Reauthorization Act (FDARA), which governs FDA’s authority to collect user fees from the industry it regulates in order to fund core FDA programs.
On July 28, the Food and Drug Administration (FDA) announced a new strategy to address tobacco-related disease and death. The agency seeks to develop a plan to reduce the nicotine levels in combustible cigarettes to non-addictive levels. However, as part of the strategy, the FDA also announced it will delay the regulation of e-cigarettes for several years. This regulation was part of the implementation of the Deeming Rule 2021/2022, which was issued last year.
On August 3, 2017, the U.S. Food and Drug Administration granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS™, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.
On August 2, 2017, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica®, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.
On July 31, 2017, the U.S. Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
On August 1, 2017, the U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA®, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
The U.S. Food and Drug Administration (FDA) has released a guidance, effective immediately, allowing for an Institutional Review Board (IRB) to waive informed consent requirements for clinical investigations that include adequate protections for human subjects and present a minimal risk.