The following is a Drug Safety statement from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research:
ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action.
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On January 15, 2021, the Food and Drug Administration granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis.
On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Clinician well-being is a major priority for physicians and practices, and it contributes to quality patient care. A recent survey of ASCO’s membership that found that 45% of medical oncologists reported experiencing emotional exhaustion and/or depersonalization symptoms related to burnout. On Tuesday, January 26, 2021 from 3:30 – 5:00 p.m. ET, the American Society of Clinical Oncology (ASCO) will host an interactive town hall-style webinar to share ASCO’s plans and resources to address this ongoing issue, and to hear members’ perspectives.
On the eve of his inauguration, the Association for Clinical Oncology (ASCO) congratulates Joseph R. Biden, Jr., the 46th President of the United States.
On January 14, 2021, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
On January 7, 2021 Department of Health and Human Services (HHS) Secretary Alex Azar extended the COVID-19 Public Health Emergency (PHE) declaration for an additional 90 days, effective January 21.
The Centers for Medicare & Medicaid Services (CMS) announced a revised Medicare Physician Fee Schedule (PFS) Conversion Factor (CF) of $34.8931 for 2021. This represents a 3.3% reduction from the 2020 CF of $36.0869. CMS updated the CF as a result of a provision in the $1.4 trillion Consolidated Appropriations Act of 2021 (H.R 133), which was signed into law on December 27, 2020.
On December 28, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction blocking implementation of the Most Favored Nation (MFN) Model. The decision prevents the Centers for Medicare & Medicaid Services (CMS) from implementing the MFN Model until the agency completes the notice and comment procedures required by the Administrative Procedure Act, which requires CMS to solicit comments on a proposal and respond to those comments before finalizing any rules implementing a new payment model. ASCO submitted an amicus curiae brief in support of the this litigation, and others, to enjoin implementation of the model.
The Association for Clinical Oncology responded to two requests for information from the Department of Health and Human Services. One Request for Information sought stakeholder feedback and recommendations on which of the temporary regulatory flexibilities instituted during the COVID-19 Public Health Emergency (PHE) should be extended beyond the PHE. The other asked for information on leveraging novel technologies to manage chronic diseases in aging populations living in underserved areas.
On December 23, 2020, ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the Reducing Provider and Patient Burden and Promoting Patients' Electronic Access to Health Information proposed rule. This rule builds on the CMS Interoperability and Patient Access final rule and would require Medicaid and Children’s Health Insurance Program (CHIP) managed care plans, state Medicaid and CHIP fee-for-service programs, and Qualified Health Plan (QHP) issuers on federally facilitated insurance exchanges to improve the electronic exchange of health care data, and streamline processes related to prior authorization.
Feasibility assessments (FA) for clinical trials are conducted to establish that prospective trial sites can safely and effectively meet study goals and protocol requirements, however, a new research statement by the American Society of Clinical Oncology (ASCO) asserts that current standards are “costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness.” These deficiencies ultimately result in fewer patients with timely access to clinical trials and delays in advancing novel safe and effective treatments.