On June 24, 2022, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma.
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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“The Association for Clinical Oncology (ASCO) applauds the Food and Drug Administration’s (FDA) decision to remove Juul products from the market in the United States (U.S.). This is an important step in preventing another generation from becoming addicted to nicotine—regardless of how it is delivered.”
On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for patients with wild-type BRAF solid tumors.
The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the fiscal year (FY) 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long‑Term Care Hospital (LTCH) Prospective Payment System (PPS) proposed rule. ASCO’s Comments address CAR-T reimbursement and respond to several Requests for Information (RFI) on social determinants of health data collection, measuring healthcare disparities across CMS’s quality programs, climate change, and advancing digital quality.
The Supreme Court released a unanimous decision in American Hospital Association et al. v. Becerra, Secretary of Health and Human Services, et al. in favor of the American Hospital Association (AHA) and its objection to reduced reimbursement rates for Medicare Part B drugs purchased through the 340B drug pricing program.
ASCO is continuing to collaborate with State Affiliates and outside stakeholders to raise awareness and facilitate implementation of the CLINICAL TREATMENT Act, which requires all states and territories to cover and reimburse routine costs of care for treating a Medicaid enrollee who is participating in a qualifying clinical trial.
The U.S. House of Representatives passed its comprehensive legislation to reauthorize the Food and Drug Administration (FDA) user fee agreements, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). ASCO is pleased that several of the Association’s priorities were included in the final House-passed bill.
From June 10-15, delegates from the Association for Clinical Oncology (ASCO) participated in the 2022 Annual Meeting of the American Medical Association’s (AMA) House of Delegates (HOD). The AMA HOD is the principal policy-making body of AMA and meets twice a year to discuss pressing issues and establish association policies. This year, the meeting returned to an in-person format in Chicago.
The AMA HOD voted to approve two ASCO-backed resolutions during the meeting:
Prior authorization requires patients or their providers to secure pre-approval as a condition of payment or insurance coverage of services. In a recent ASCO survey, 75% of oncology practices cited prior authorization as a significant practice pressure. In a 2021 survey led by the American Medical Association (AMA), practices reported an average of 41 prior authorization requests per week, accounting for approximately 13 hours of practice time—or nearly two business days. Learn more.
On June 8, CancerLinQ® LLC and HealthVerity, Inc. announced a collaboration that will create the nation’s premier real-world oncology data ecosystem to advance cancer care and research for government and public health agencies.
The American Society of Clinical Oncology (ASCO) has made new resources available through its refreshed Survivorship Compendium—an online library of practice tools designed and curated to help oncologists develop high-quality, equitable cancer survivorship care programs and improve existing programs for patients who have completed their initial cancer treatment or who have transitioned to maintenance or preventive therapies.
The Centers for Medicare & Medicaid Services Office of Minority Health’s Minority Research Grant Program recently released a notice of funding opportunity for three grants totaling up to $1 million for researchers at minority-serving institutions. Eligible institutions include Historically Black Colleges and Universities, Hispanic-Serving Institutions, Asian American and Native American Pacific Islander-Serving Institutions, and Tribal colleges and Universities.
In a collaboration announced June 4, ASCO will work with the World Health Organization (WHO) to measure and improve the quality of cancer care internationally. The goal is to achieve health-related targets of the U.N. Sustainable Development Goals and WHO Global Action Plan on Non-Communicable Diseases and help cancer professionals provide the best possible care to their patients.
On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC):
On May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.