Industry News

  • FDA Approves Nivolumab for Completely Resected Esophageal or GEJ Cancer

    On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Posted 5/21/2021



  • FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma

    The Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.

    Read the prescribing information and medication guide.

    Posted on 4/30/2021



  • FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

    On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

    Read the FDA announcement.

    Read the BMS announcement.

    Posted 4/16/2021



  • FDA Approves Idecabtagene Vicleucel for R/R Multiple Myeloma

    On March 26, 2021, the U.S. Food and Drug Administration approved idecabtagene vicleucel as the first B-cell maturation antigen directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Read the bluebird bio, Inc. announcement.

    Posted 3/29/21



  • FDA Approves Trastuzumab-qyyp Biosimilar

    The U.S. Food and Drug Administration approved the 150 mg single-dose vial of trastuzumab-qyyp (Trazimera®, Pfizer)—a biosimilar to Herceptin® (trastuzumab).

    Read the full prescribing information.

    Posted on 3/11/2021



  • FDA Approves Bevacizumab-bvzr for New Indication

    The U.S. Food and Drug Administration approved the inclusion of epithelial ovarian, fallopian tube, and primary peritoneal cancer to the indications of bevacizumab-bvzr (Zirabev®, Pfizer). 

    Read the full prescribing information.

    Posted on 3/11/2021



  • FDA Approves Melphalan Flufenamide for R/R MM

    On February 26, 2020 the U.S. Food and Drug Administration (FDA) approved melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

    Read Oncopeptides' announcement.

    Posted 3/1/21



  • FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma

    On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Posted 2/8/2021


  • New FDA-Approved Indication for Crizotinib Capsules

    The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for crizotinib (Xalkori®, Pfizer) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic leukemia kinase-positive. 

    Read the Full Prescribing Information.

    Read the Press Release.

    Posted 1/26/2021



  • FDA Approves Nivolumab + Cabozantinib for Advanced RCC

    On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

    Read Bristol Myers Squibb's announcement.

    Read the FDA announcement.

    Posted 1/22/2021



  • Registration Open: Jakafi (ruxolitinib) Product Theater

    Intervening With Jakafi® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion 

    incyte-logoJakafi® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the  treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

    Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi® (ruxolitinib) in treating your patients. 

    Monday, November 30
    12:00 - 1:00 PM EST

    Presented by:
    Solomon Hamburg, MD, PhD
    Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
    UCLA Beverly Hills Hematology Oncology
    REGISTER

    Monday, November 30
    3:00 - 4:00 PM EST

    Presented by:
    Jonathan Abbas, MD
    Director, Acute Leukemia Program
    Tennessee Oncology
    REGISTER



  • FDA Approves Expanded Indication of Pembrolizumab for R/R cHL

    On October 15, 2020, the U.S. Food and Drug Administration (FDA) approved an expanded label for Keytruda® (pembrolizumab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory cHL after frontline therapy.

    Read Merck's press release and the FDA announcement.

    Posted 10/15/2020


  • FDA Approves Nivolumab + Ipilimumab Immunotherapy Treatment for Mesothelioma

    On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.

    Read the FDA Announcement.

    Read the Bristol Myers Squibb Announcement.

    Posted 10/5/2020 



  • CMS Releases RO Model Final Rule

    On Friday, September 18, 2020 the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Radiation Oncology (RO) Model. The RO Model seeks to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether bundled, prospective, site neutral, modality agnostic, episode-based payments to physician group practices, hospital outpatient departments, and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. The RO Model has a five-year Model performance period that begins on January 1, 2021 and runs through December 31, 2025.

    For additional information on the final rule and the model, please visit the radiation oncology website. The following resource documents about RO may also be helpful: Press ReleaseFact Sheet, and Final Rule. For questions regarding the RO Model, please reach out to the RO Model Helpdesk by phone: 1.844.711.2664, option 5; or email: RadiationTherapy@cms.hhs.gov.

    Posted 9/18/2020



  • CMS Issues FY2021 IPPS and LTCH Final Rule

    On September 2, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule, which includes important provisions designed to ensure access to potentially life-saving diagnostics and therapies for hospitalized Medicare beneficiaries. The changes will affect approximately 3,200 acute care hospitals and approximately 360 Long-Term Care Hospitals. CMS estimates that total Medicare spending on acute care inpatient hospital services will increase by about $3.5 billion in FY 2021, or 2.7 percent. 

    CMS’ rule creates a new Medicare Severity Diagnostic Related Group (MS-DRG) that provides a predictable payment to help adequately compensate hospitals for administering Chimeric Antigen Receptor (CAR) T-cell therapies.

    Also in the final rule, CMS approved a record number of 24 new technology add-on payments, which is an additional payment to hospitals for cases involving eligible new and relatively high cost technologies. This will provide additional Medicare payment for these technologies while real-world evidence is emerging, giving Medicare beneficiaries timely access to the latest innovations.

    Read the fact sheet and final rule from the Federal Register.

    Posted 9/2/2020



  • CMS Releases CY 2021 OPPS and PFS Proposed Rules

    On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment Proposed Rule (CMS-1736-P). ACCC and council are reviewing these proposed rules and will be providing comments.

    Until this analysis is complete, read the proposed OPPS rule and the proposed PFS rule. Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your cancer program.


    Posted 8/6/2020



  • FDA Approves Pembrolizumab for Treatment of TMB-H Solid Tumors

    On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

    On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.

    Read the FDA announcement.

    Posted 6/17/2020



  • CMS Issues Product-Specific J-code for Adakveo®

    Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg.

    The new and unique J-code replaces all previous HCPCS codes for crizanlizumab-tmca (Adakveo®, Novartis) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types.

    Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (injection, crizanlizumab-tmca, 1 mg, hospital outpatient).

    See full prescribing information.

    Posted 6/12/20




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