FDA Approvals
The Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.
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The Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
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The Food and Drug Administration (FDA) has required this safety notice as part of the COPIKTRA REMS (Risk Evaluation
and Mitigation Strategy) to inform about updates to the Prescribing Information in July 2024.
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US FDA adds label warning to J&J’s and Legend Biotech’s cancer therapy.
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The Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
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State and National Legislative & Regulatory Issues
The Board of Pharmacy’s compounding regulations are now effective. The approved regulations clearly exempt physicians, which is something CMA advocated for throughout the process. This rulemaking package was of interest to multiple specialties.
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CMS has instructed all Medicare Administrative Contractors (MACs) to continue temporarily holding claims with dates of service on or after October 1, 2025, for services impacted by the expired Medicare legislative payment provisions under the Full-Year Continuing Appropriations and Extensions Act, 2025.
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Effective Oct. 1, oncology practices will have a wide range of new International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM) coding options, thanks to the 2026 code set that will take effect then.
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National Guideline Updates
NCCN Guidelines Navigator for Breast Cancer Genetic Testing and Treatment Debuts During Breast Cancer Awareness Month.
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ASCO News and Updates
In a study reported in JCO Oncology Practice, Kirkwood et al identified recent changes in and characteristics of the hematologist/medical oncologist (oncologist) workforce in the United States, with the data revealing gaps in coverage according to age and other patient demographics.
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ASCO Members: How is the Government Shutdown Impacting You?
The Association for Clinical Oncology (ASCO) is urgently collecting stories on how the government shutdown is impacting our members’ ability to provide patient care and conduct research.
Please share examples concerning delays to critical services or the interruption of cancer trials and research activities.
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ASCO Edge – Essential Practice Management Education for Oncology Professionals
The American Society of Clinical Oncology (ASCO) ASCO Edge initiative, an online oncology practice and operations management educational series developed by oncology professionals for oncology professionals. ASCO Edge content is a member-only benefit that provides members with education and the tools to effectively manage the business side of their practices. Through modules covering topics from employment law to leadership and succession planning, members will gain the foundational understanding and advanced insights needed to effectively manage practice operations and continue to deliver exceptional patient care. Please share this with your membership and encourage them to get started today.
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ACT Now! Tell Congress to Make Telehealth Flexibilities Permanent
Medicare telehealth flexibilities expired on September 30. It’s crucial that Congress hears from you today about the importance of continued access to telehealth services for patients with cancer.
Due to Congress’s lack of action, pre-pandemic telehealth restrictions are back in place, meaning that patients have to be in a designated rural area and go to an approved site, rather than their own homes, to receive telehealth care.
For patients with cancer, telehealth provides essential access to care for those who need it most, and we must tell Congress to make the previous telehealth flexibilities permanent by supporting the CONNECT for Health Act (H.R. 4206/ S. 1261). Please ask your members to urge your lawmakers to restore our patients’ access to telehealth!
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Corporate Member Highlights
From Be One Medicines: BRUKINSA tablets will be available in late October 2025.
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The American Cancer Society and Pfizer have launched a three-year initiative, “Change the Odds,” aimed at improving health outcomes in medically underrepresentedcommunities across the United States by increasing awareness of and access to: Cancer Screenings, Patient Support & Navigation and Clinical Trials
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