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ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial aiming to describe the performance of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer with a potentially actionable genomic variant.
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This article examines recent efforts to regulate pharmacy benefit managers (PBMs). Since 2017, states have enacted more than 150 laws to regulate PBMs. These laws regulate the way PBMs interact with different entities, including pharmacies, health plans, state governments, and patients.
On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).
President Biden announced Nov. 17 the appointment of W. Kimryn Rathmell, MD, PhD, Chair of Medicine at Vanderbilt University Medical Center, and Physician-in-Chief for Vanderbilt University Adult Hospital and Clinics, as his choice for director of the National Cancer Institute (NCI).
Delegates from the Association for Clinical Oncology (ASCO) gathered in Washington to participate in the 2023 Interim Meeting of the American Medical Association (AMA) House of Delegates (HOD) from Nov. 10-14.
On November 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
On November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
Congress passed a continuing resolution (CR) on November 15, 2023, that extends FY 2023 federal funding levels until February 2, 2024, for all Department of Health and Human Services agencies.
On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
On November 7, 2023, the Food and Drug Administration revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.
On November 8, 2023, the Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
The Centers for Medicare & Medicaid Services issued a proposed rule that would update Medicare Advantage, the Medicare Prescription Drug Benefit Program, the Medicare Cost Plan program, Programs of All-Inclusive Care for the Elderly, and the Health Information Technology Standards and Implementation Specifications in 2025. The proposal aims to strengthen beneficiary protections from misleading marketing, promote equity in coverage, improve prior authorization, promote access to behavioral health care providers, and improve supplemental benefits. Important provisions for the cancer care community are listed.
The Senate has confirmed Monica M. Bertagnolli, MD, FACS, FASCO, as the 17th director of the National Institutes of Health (NIH). She served as president of the American Society of Clinical Oncology from 2018-2019 and is an accomplished cancer surgeon and researcher with deep expertise in community-based cancer research. While the director of the National Cancer Institute, Dr. Bertagnolli played a critical role in elevating the goals of the Cancer Moonshot initiative through the comprehensive National Cancer Plan and ASCO is excited to celebrate her new role leading the nation’s top federal medical research agency.
The Department of Health and Human Services issued a proposed rule that would establish penalties for providers who do not comply with the information blocking requirements established by the 21st Century Cures Act.
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the 2024 Medicare Physician Fee Schedule (MPFS) and updates to the Quality Payment Program (QPP). The Association for Clinical Oncology (ASCO) is still assessing these rules and has provided a preliminary analysis and key provisions for the cancer care community.
On October 31, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC).
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