On May 24, 2019, the Food and Drug Administration approved alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
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 May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI®, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
CancerLinQ LLC hosted a webinar on May 16, that showed new tools within the CancerLinQ® platform that allow for automated quality reporting to the Merit-based Incentive Payment System (MIPS) and ASCO’s QOPI Certification Program.
Positive findings from fully enrolled cohorts in non-small cell lung cancer and metastatic breast cancer from ASCO's Targeted Agent and Profiling Utilization Registry (TAPUR™) Study will be presented in poster sessions at the 2019 ASCO® Annual Meeting. In addition, the study is being expanded to include patients with active brain metastases and three new drug therapies. Pharmaceutical company Boehringer Ingelheim has also joined the study and, later this year, will provide afatinib (Gilotrif®) to participants who enroll in a tissue-agnostic cohort of patients with an NRG1 gene fusion. That same month, the TAPUR Study also will add two new drugs from existing pharmaceutical company collaborators: abemaciclib (Verzenio®, Eli Lilly and Company) and talazoparib (Talzenna®, Pfizer).
On May 16, the Centers for Medicare & Medicaid Services (CMS) released a final rule on drug coverage policies. After receiving feedback from the American Society of Clinical Oncology (ASCO) and other stakeholders, CMS did not finalize a proposal that would have impeded access to drugs within Medicare Part D’s Six Protected Classes. The agency did, however, finalize a proposal to allow the use of step therapy for protected class prescription drugs under Medicare Advantage and Part B—despite stakeholder concerns.
ASCO members are encouraged to use the ACT Network to tell their representatives in Congress to support the CLINICAL TREATMENT Act and protect patient access to clinical trials.
ASCO submitted comments to a U.S. House Energy & Commerce health subcommittee hearing entitled, “Improving Drug Pricing Transparency and Lowering Prices for American Consumers." The hearing focused on several bills aimed at increasing transparency around drug prices and lowering out-of-pocket costs for patients. ASCO’s comments offer the oncology community’s perspective on several of the bills discussed during the hearing and focus on improving access to affordable cancer care.
This week, Senate Majority Leader Mitch McConnell (R-KY) and Senator Tim Kaine (D-VA) introduced the “Tobacco-Free Youth Act” which will work to protect youth from tobacco products and electronic nicotine delivery systems by raising the national age of sale to from 18 to 21. ASCO endorsed the legislation in a letter from ASCO President Monica M. Bertagnolli, MD, FACS, FASCO.
On May 13, ASCO members joined more than 100 volunteers representing One Voice Against Cancer (OVAC) on Capitol Hill for a grassroots lobby day in support of federal research funding. OVAC is a coalition of organizations representing cancer researchers, physicians, and nurses – as well as patients, survivors, and their families – focused on long-term, sustained federal funding for cancer research and prevention.
The American Society of Clinical Oncology (ASCO) applauds the Centers for Medicare & Medicaid Services (CMS) for listening to ASCO and other stakeholders by not finalizing a proposal that would have significantly impacted access to drugs within the Six Protected Classes.
On May 16, 2019, the Food and Drug Administration approved dalteparin sodium (FRAGMIN®, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older.
A new study published today in the Journal of Oncology Practice (JOP) reveals the findings of a 2018 ASCO Oncology Workforce survey on oncologists’ perceptions and practice behaviors related to diet, physical activity, and weight management in people with cancer — during and after active treatment.
On May 15, 2019, the Food and Drug Administration approved venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO, announced today that CureMD’s Electronic Health Record (EHR) system is the third to be certified by CancerLinQ® after meeting criteria for interoperability and data standardization. This collaboration will streamline access to CancerLinQ® and drive interoperability among EHR systems.