New results from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study demonstrate that single-agent palbociclib has no meaningful clinical activity in patients with CDKN2A mutated or deleted advanced pancreatic adenocarcinoma and cholangiocarcinoma.
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 16, 2019, the Food and Drug Administration approved fedratinib (INREBIC®, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
On August 15, 2019, the Food and Drug Administration granted accelerated approval to entrectinib (ROZLYTREK™, Genentech Inc.) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.
Last week, ASCO submitted a comment letter to Alex M. Azar II, Secretary of Health and Human Services (HHS), regarding the proposed rule on Sec. 1557 of the Affordable Care Act (ACA)—Nondiscrimination in Health and Health Education Programs or Activities.
On August 15, ASCO announced the three recipients of its CancerLinQ Discovery® Research Support Grant, each of whom will undertake research projects using data from CancerLinQ Discovery®, an offering of ASCO’s CancerLinQ® initiative that provides de-identified data from cancer patients to academic researchers, government agencies, and others in the oncology community to generate practical knowledge that will improve cancer care.
Applications are now open for grant funding for 10 oncology practices in rural or urban centers in the U.S. that primarily treat underserved populations to participate in ASCO’s Quality Oncology Practice Initiative (QOPI®) and Quality Training Program offerings for a three-year period. The generous grant for more than $600,000 has been provided by the Stavros Niarchos Foundation, and it will fund each practice’s training and participation.
ASCO President Howard A. “Skip” Burris III, MD, FACP, FASCO, made a statement applauding the Centers for Medicare & Medicaid Services (CMS) for releasing a national coverage determination (NCD) on CAR T-cell therapy that provides consistent and predictable access to an innovative cancer treatment to Medicare beneficiaries nationwide.
The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover Food and Drug Administration (FDA)-approved Chimeric Antigen Receptor T-cell (CAR T-cell) therapy for certain patients with cancer.
Precision medicine treatments (otherwise known as targeted therapies) have the potential to improve outcomes for patients with advanced cancer. Over the last 5 years, 20% of the U.S. Food and Drug Administration’s (FDA) drug approvals have been for precision medicine treatments. With so many treatments coming onto the market, it can be challenging for oncologists to navigate the options available to identify the right treatment for each patient.
ASCO recently submitted comments to the Food and Drug Administration (FDA) regarding the agency’s draft guidance recommending specific approaches for sponsors of clinical trials to broaden eligibility criteria, redesign clinical trials, and remove patient barriers to increase enrollment of underrepresented populations in their clinical trials.
On August 2, the Centers for Medicare & Medicaid Services (CMS) released the Hospital Inpatient Prospective Payment System (IPPS) final rule for fiscal year (FY) 2020. The rule finalizes changes that will affect all U.S. hospitals, including:
Applications are now open for oncology practices in 11 specific U.S. urban centers with high proportions of African-American patients with breast cancer to participate in ASCO’s Quality Oncology Practice Initiative (QOPI®), QOPI® Certification, and Quality Training Program (QTP). Susan G. Komen® is providing training and funding support.
On August 2, 2019, the Food and Drug Administration approved pexidartinib (TURALIO™, Daiichi Sankyo) capsules for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT.
The Centers for Medicare & Medicaid Services (CMS) recently announced a new voluntary pilot program that will give select providers access to Medicare claims data staring in January 2020. The “Data at the Point of Care” (DPC) pilot, which is part of the MyHealthEData Administration-wide initiative led by the White House Office of American Innovation, will allow participating providers to fill in information gaps by providing access to structured and complete claims data, including previous patient diagnoses, past procedures, and medication lists. Medicare beneficiaries give permission for this data to be shared in their early sign-up for Medicare and can always opt-out of their claims data being shared.
ASCO submitted comments to a Senate Finance Committee markup on the “The Prescription Drug Pricing Reduction Act (PDPRA),” a package of proposals aimed at addressing the high cost of prescription drugs.