On February 28, 2019, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta™, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.
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.
To sign up for advocacy alerts, log in to ASCO.org with your ASCO member or guest account, and visit the subscription center available under your account profile.
ASCO Chief Medical Officer Dr. Richard Schilsky recently joined ASCO CEO Dr. Clifford A. Hudis to discuss the 2019 Clinical Cancer Advances (CCA) report on the ASCO in Action Podcast. The CCA report identifies the most important clinical research advances from the past year across the full trajectory of cancer care, ranging from prevention and screening to treatment and survivorship.
ASCO members who are practicing oncologists may have received an email inviting them to participate in the American Medical Association’s Specialty Society Relative Value Scale Update Committee survey for physician office visits and a new prolonged services code. This important survey will help ASCO, in concert with the RUC, recommend accurate relative values for physician work and direct practice expenses to the Centers for Medicare & Medicaid Services and ASCO members are encouraged to participate if they are invited to take the survey.
On February 22, 2019, the Food and Drug Administration approved trifluridine/ tipiracil tablets (LONSURF®, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
On February 25, 2019, the Journal of Oncology Practice published an article on precision medicine as part of the State of Cancer Care in America series, which highlights existing challenges and offers three distinct examples of oncology practices successfully implementing precision medicine programs.
WebMD recently recognized Karen M. Winkfield, MD, PhD, as its 2018 Advocate Health Hero for her efforts in working for equal access to high-quality cancer care.
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.
On February 20 ASCO announced that it is seeking applications for research grants for projects that use data from CancerLinQ Discovery®, an offering of ASCO’s CancerLinQ® initiative, as a source.
Urge Congress to support the CLINICAL TREATMENT Act, which would guarantee coverage of the routine care costs of clinical trial participation for Medicaid enrollees with a life-threatening condition.
On February 11, the Office of the National Coordinator for Health IT (ONC) released its long-anticipated proposed rule on information blocking, interoperability, and the Health IT Certification program.
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.
Approximately 5 million middle and high school students reported currently using a tobacco product, with over 3.6 million currently using e-cigarettes and about half (2.5 million) currently using a combustible tobacco product, according to the latest findings from the National Youth Tobacco Survey (NYTS).
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 11, JCO CCI Clinical Cancer Informatics (JCO CCI) published its third special collection of articles, this one on the topic of “Decision Making in Oncology.” This collection examines decision making in oncology and the benefits and challenges of various tools and methods.