The Department of Health and Human Services (HHS) has announced further delay for implementation of the updated Common Rule until January 2, 2019.
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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The Journal of Oncology Practice (JOP) launched a new care delivery blog, JOP DAiS (Discussion & Analysis in Short), to serve as a forum for commentary and analysis on issues affecting the mechanisms of oncology care delivery. This new platform will be a way to collaborate, debate, and discuss many of the topics JOP addresses in its publication including health services research, business and socioeconomics, ethics, and health policy.
A new review article in the Journal of Oncology Practice reexamines the roles of a principal investigator in the current environment of rapid drug discovery and development. The review outlines the increasing responsibilities of a principal investigator, the important role they play in compliance, and how those in the field can prepare to become a successful principal investigator.
On June 15, the Journal of Oncology Practice published an ASCO article examining the state of oncology practice in the United States as part of its new State of Cancer Care in America™ article series. The State of Oncology Practice in America, 2018 reports on important trends in oncology practice ownership, practice concerns, and the oncology workforce, along with details on the size, geographical distribution, and number of practices currently open in the United States.
The findings from the National Youth Tobacco Survey (NYTS) show decreases in the use of cigarettes, cigars, smokeless tobacco, pipes, and bidis, and saw an increase in e-cigarette use from 2011 to 2017.
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.
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.
On June 8, 2018, the Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
ASCO has officially endorsed a statement by the 70 National Cancer Institute (NCI)-designated cancer centers calling for increased HPV vaccination and screening to eliminate human papillomavirus (HPV)-related cancers. The full uptake of the vaccine and screening could prevent 12,000 cervical cancers and nearly 40,000 other HPV-related cancers (oropharyngeal, anal, penile, vulvar, and vaginal cancers) among men and women annually in the United States.
On June 7, a new article published in JCO Clinical Cancer Informatics, “Applied Informatics Decision Support Tool for Mortality Predictions in Patients With Cancer,” reports on a prediction model the authors developed to identify patients with high mortality risk prior to the start of treatment regimens.
On June 4, 2018, the Food and Drug Administration approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH) as a biosimilar to Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
On June 6, 2018, the One Voice Against Cancer Coalition (OVAC) will hold an “Online Day of Action” to advocate for increased funding for the National Institutes of Health (NIH) and the National Cancer Institute (NCI).