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Oncology Newsfeed

  • FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

    On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib for adult and pediatric patients at least a year old, with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. 

    For more information, read the FDA announcement. 

    Posted 7/19/2022 



  • CMS Announces CY 2023 HOPPS Proposed Rule

    On July 15, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Medicare Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, including proposals that align with several key goals of the Biden Administration like advancing health equity in rural areas, promoting competition in the healthcare system, and promoting safe, effective, patient-centered care.

    For more information, read the proposed rule and the CMS fact sheet.

    Posted 7/18/2022



  • CMS Stakeholder Call: Strategic Plan Update

    Administrator of the Centers for Medicare & Medicaid Services (CMS) Chiquita Brooks-LaSure and her leadership team will provide an update on the agency's recent accomplishments, including how its initiatives are advancing the CMS strategic plan. 

    When: July 19, 2022 from 1:00-2:00 PM EDT.

    Who: National and local CMS stakeholders and partners.

    Register to attend and visit the CMS website for more information. 

    Posted 7/14/2022



  • CMS Announces CY 2023 PFS Proposed Rule

    On July 7, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Physician Fee Schedule (PFS) proposed rule, which would significantly expand access to behavioral health services, Accountable Care Organizations (ACOs), cancer screening, and dental care—particularly in rural and underserved areas.

    “Integrated coordinated, whole-person care—which addresses physical health, behavioral health, and social determinants of health—is crucial for people with Medicare, especially those with complex needs,” said Dr. Meena Seshamani, deputy administrator at CMS and director of the Center for Medicare. “If finalized, the proposals in this rule will advance equity, lead to better care, support healthier populations, and drive smarter spending of the Medicare dollar.

    For more information, read the proposed rule as well as the CMS press release and fact sheet.

    Posted 7/8/2022


  • CMS Announces the Enhancing Oncology Model

    On June 27, 2022, the Biden Administration, through the Department of Health and Human Services and Centers for Medicare & Medicaid Services (CMS), announced a new model to improve cancer care for Medicare patients: the Enhancing Oncology Model (EOM). This model is the successor to the Oncology Care Model (OCM).

    The EOM—designed by the Center for Medicare and Medicaid Innovation—will tackle the health inequities and meet patients' throughout the cancer care continuum, with an emphasis on person-centered care and better patient outcomes. The model will run from July 2023 through June 2028, and its participants will include oncology practices that treat people with Medicare undergoing chemotherapy for breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer. 

    For additional information regarding the EOM, visit the CMS website. Then read ACCC's statement.

    Posted 6/29/2022



  • FDA Approves Dabrafenib + Trametinib for Metastatic Solid Tumors

    On June 22, 2022, the U.S Food and Drug Administration (FDA) approved dabrafenib and trametinib for the treatment of adult and pediatric patients 6 years of age and older, with unresectable or metastatic solid tumors with BRAF V600E mutation, who have progressed following prior treatment and have no satisfactory alternative treatment options.

    For more information, read the FDA announcement and the Novartis announcement. 

    Posted on 6/29/2022


  • FDA Approves Lisocabtagene Maraleucel for Refractory Large B-Cell Lymphoma

    On June 24, 2022, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
    • Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy
    • Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
    For more information, read the FDA announcement and Bristol Myers Squibb's announcement.

    Posted 6/28/2022


  • FDA Approves FoundationOne CDx for Entrectinib

    On June 9, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne®CDx as a companion diagnostic for two entrectinib indications:

    1. To identify patients with ROS1-positive non-small cell lung cancer

    2. To identify patients with neurotrophic tyrosine receptor kinase fusion-positive solid tumors.

    Both indications are for patients who may be appropriate for treatment with entrectinib.

    For more information, read Foundation Medicine's announcement and Roche's announcement.

    Posted 6/9/2022



  • FDA Approves Pegfilgrastim-pbbk Biosimilar

    On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved Amneal's biologics license application for Fylnetra™ (pegfilgrastim-pbbk), a biosimilar referencing Neulasta® (Agmen).

    For more information, read Amneal's announcement. 

    Posted 5/31/2022



  • FDA Approves Two Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma

    On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status. 

    For more information, read Bristol Myers Squibb's announcement.

    Posted 5/31/2022