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Oncology Newsfeed

  • FDA Approves Crizotinib for Children and YA Patients with R/R ALCL

    On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year of age and older and young adults (YA) with relapsed or refractory (R/R), systemic anaplastic large cell lymphoma (ALCL)  that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive  ALCL.

    Read the FDA announcement.

    Read Pfizer's announcement.

    Posted 1/15/2021



  • CMS Releases C-Code for Belantamab Mafodotin-blmf

    The Centers for Medicare and Medicaid Services (CMS) released the C-code C9369 (injection, belantamab mafodontin-blmf, 0.5 mg) for GlaxoSmitheKline's Blenrep (belantamab mafodotin-blmf), effective January 1, 2021.

    Posted 1/5/2021



  • FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.

    Read the FDA announcement.

    Read AstraZeneca's announcement.

    Posted 12/21/2020


  • FDA Approves Relugolix for Advanced Prostate Cancer

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved relugolix for the treatment of adult patients with advanced prostate cancer. It is the first and only oral gonadotropin-releasing hormone receptor antagonist for men with advanced prostate cancer.

    Read the FDA announcement.

    Read Myovant Sciences' announcement.

    Posted 12/21/2020


  • FDA Approves Selinexor for R/R Multiple Myeloma

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior

    therapy. Selinexor was previously approved under the FDA's accelerated approval program for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

    Read the FDA announcement.

    Read Karyopharm Therapeutics' announcement.

    Posted 12/21/2020


  • FDA Issues EUA for Moderna's COVID-19 Vaccine

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The FDA has determined that the vaccine has met the statutory criteria for issuance of an EUA.

     

    Read the FDA announcement.

    Posted 12/18/2020



  • FDA Approves Amgen's Rituximab Biosimilar

    On December 17, 2020, the U.S. Food and Drug Administration (FDA) approved Amgen's rituximab biosimilar Riabni™ (rituximab-arrx)which references Rituxan® (rituximab) and is indicated for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

    Read Amgen's announcement.

    Posted 12/18/2020



  • FDA Approves Margetuximab for Patients with Metastatic HER2+ Breast Cancer

    On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

    Read the FDA announcement.

    Read MacroGenics' announcement.

    Posted 12/17/2020



  • FDA Issues EUA for First COVID-19 Vaccine

    On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows Pfizer and BioNTech's COVID-19 vaccine to be distributed in the United States. The FDA has determined that the vaccine has met the statutory criteria for issuance of an EUA.

     

    For more information on the FDA's emergency use authorization, read the FDA announcement.

     

    Posted 12/12/20



  • CMS Announces "PFS Final Rule: Understanding 4 Key Topics Call"

    The Centers for Medicare & Medicaid Services (CMS) announces its "Physician Fee Schedule Final Rule: Understanding 4 Key Topics Call" scheduled for December 10, 2020. During this call, CMS experts will briefly cover provisions from the final rule and address participants' questions.

    The target audience for this call is: Medicare Part B Fee-for-Service clinicians; office managers and administrators; state and national associations that represent health care providers; and other stakeholders.

    You can register for this event on the CMS website. CMS encourages participants to review the final rule prior to the call.

    Posted 12/03/2020