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  • FDA Approves Atezolizumab for 1st-Line Treatment in Some Advanced NSCLC

    On May 18, 2020, the U.S. Food and Drug Administration approved atezolizumab (Tecentriq®) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations.

    On the same day, the FDA also approved the VENTANA PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with atezolizumab.

    Read the full FDA announcement

    Posted 5/19/2020



  • New Name for Takeda Oncology Patient Support Program

    Effective May 18, 2020, Takeda Oncology has changed the name of its patient support program from "Takeda Oncology 1Point" to "Takeda Oncology Here2AssistTM". Patients and providers will continue to receive the same high level of comprehensive, personalized support.

    Read corporate announcement.



  • FDA Approves Ripretinib for Previously Treated Advanced GIST

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

    Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with GIST who were previously treated with imatinib, sunitinib, and regorafenib. 

    Read the full FDA announcement

    Posted 5/15/2020



  • FDA Approves Rucaparib for Pretreated BRCA-Mutated mCRPC

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial in 115 patients with BRCA-mutated (germline and/or somatic) mCRPC who had been treated with androgen receptor-directed therapy and taxane-based chemotherapy.

    Read full FDA announcement.

    Posted 5/15/2020


  • FDA Approves Nivolumab + Ipilimumab Combination for Metastatic NSCLC

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

    The FDA also approved the PD-L1 IHC 28-8 pharmDx (Agilent Technologies, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with nivolumab plus ipilimumab.

    Read full FDA announcement

    Posted 5/15/2020


  • FDA Grants Accelerated Approval to Pomalidomide for Karposi Sarcoma

    On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy (HAART) and Kaposi sarcoma in adult patients who are HIV-negative.

    This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Read the FDA announcement.

    Posted 5/15/2020


  • NCCN/ASCO Updated Guidelines for Pegfilgrastim-cbqv

    Short-term recommendations have been made to the NCCN and ASCO guidelines regarding the use of granulocyte colony-stimulating factor (G-CSF), inclusive of pegfilgrastim-cbqv (UdenycaTM, Coherus BioSciences).

    Due to the COVID-19 pandemic, the updated NCCN and ASCO guidelines have lowered the threshold for the use of myeloid growth factors from those chemotherapy regimens which have a 20% or higher risk of febrile neutropenia to now include those regimens with a risk of 10-20%, which includes all of the intermediate risk chemotherapy regimens.

    Read Prescribing Information

    NCCN Guidelines

    ASCO Guidelines

    Posted 5/14/2020



  • Astellas' COVID-19 Pandemic Response

    Amidst the unprecedented public health challenge, Astellas and its employees continue to contribute to securing the safety of patients and alleviating strain on healthcare resources during this critical time. This includes financial assistance to support local and global communities; policies focused on the well-being of its employees, healthcare professionals, and partners; employee mobilizations, and company-matched donations to humanitarian organizations. Additionally, Astellas is ensuring that patients have access to its medicines through its Pharma Support Solutions, which offers support to patients needing access and reimbursement assistance. 

    Read Astellas' full statement on the coronovirus.

    Posted 5/13/2020



  • Merck's Response to COVID-19

    During this unprecedented time, Merck is committed to ensuring its medicines and vaccines reach its patients and customers. This includes supporting patients who might need more help today with their medications, including those who are unemployed or have lost insurance coverage due to the COVID-19 pandemic.

    To learn about what support 
    options may be available, visit Merck's Access and Patient Assistance information page.

    For more details about Merck’s response to the coronavirus, visit its COVID-19 information page.

    Posted 5/13/2020



  • FDA Approves Capmatinib Tablets for Metastatic NSCLC

    On May 6, 2020, the U.S. Food and Drug Administration (FDA) approved capmatinib (Tabrecta™, Novartis Pharmaceuticals Corporation) tablets for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

    This indication is approved under accelerated approval based on overall response rate and duration of response.

    Read the corporate press release.

    Posted 5/12/2020



  • FDA Approves Darzalex Faspro™ for Multiple Myeloma

    On May 1, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.


    Read the FDA announcement.

    Posted 5/11/2020



  • FDA Approves Olaparib + Bevacizumab as Maintenance Treatment for Advanced Ovarian Cancer

    On May 8, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic test.

    Read FDA announcement.

    Read the corporate press release. 

    Posted 5/11/2020



  • FDA Approves Selpercatinib for Lung & Thyroid Cancers with RET Mutations or Fusions

    On May 8, 2020, the U.S. Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for the following indications:

    • Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
    • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;
    • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
    Read the full FDA announcement here.
    Posted 5/11/2020


  • FDA Approves Capmatinib for Adults with Metastatic NSCLC

    On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

    On the same day, the FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib.

    Read FDA announcement

    Posted 5/6/2020



  • NAM to Host Webinar on Supporting Clinician Well-Being During COVID-19

    The National Academy of Medicine (NAM) will host a webinar on Supporting Clinician Well-Being During COVID-19 on Thursday, May 7 from 1:00 to 3:30 PM ET. Webinar objectives include:
    • Describing the existing clinician burnout crisis prior to the COVID-19 pandemic and the goals of the Action Collaborative on Clinician Well-Being and Resilience.
    • Identifying the critical needs and priorities to support the well-being of clinicians, including those in training, during the COVID-19 era.
    • Spotlighting programs, resources, and leadership efforts currently underway to address and monitor the acute and long-term mental health and well-being of clinicians on the frontlines of COVID-19.
    • Voicing the need for a coordinated, national strategy to care for the acute and long-term health and well-being of frontline clinicians delivering healthcare during this public health crisis.

    Questions for the panelists can be submitted as you register for the event and during the webinar. A recording of this webinar, slides, and transcript will be available after the event.

    More information and registration here.

    Posted 5/4/2020



  • FDA Issues Emergency Use Authorization for Remdesivir for Severe COVID-19

    On May 1, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.

    The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

    Read the full FDA announcement.

    Posted 5/1/2020


  • CMS Issues Sweeping Regulatory Waivers & Changes to Further Expand Telehealth Options

    On April 30, the Centers for Medicare & Medicaid Services (CMS) issued another round of sweeping regulatory waivers and rule changes aimed at further increasing access to telehealth for Medicare beneficiaries in response to the COVID-19 public health emergency. Among the announced changes, CMS is:

    • Expanding the types of providers able to provide services via telehealth to Medicare beneficiaries to include physical therapists, occupational therapists, and speech language pathologists.
    • Allowing hospitals to bill for telehealth services provided by hospital-based practitioners in Medicare outpatient settings (including when patients are at home when the home is serving as a temporary provider-based department of the hospital). The agency states that this might include counseling, educational, and therapy services.
    • Expanding the types of services reimbursable under Medicare for audio-only telehealth visits to include behavioral health and patient education services, and increasing reimbursement (retroactively to March 1) for audio-only telehealth visits. 
    • Waiving the video requirement for telehealth E/M services. These are now added to the list of audio-only telehealth services that are reimbursable visits.
    • Expediting the process for adding new services to the list of those Medicare services that can be provided by telehealth.
    • Permitting rural health clinics and federally qualified health clinics to provide telehealth as a distant site, thus enabling Medicare beneficiaries to receive care from home.
    Read the CMS announcement for full details.

    Posted 5/1/2020

     



  • FDA Approves Daratumumab and Hyaluronidase-fihj for Multiple Myeloma

    On May 1, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.

    Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received:

    • in combination with bortezomib, melphalan and prednisone  in newly diagnosed patients who are ineligible for autologous stem cell transplant,
    • in combination with lenalidomide and dexamethasone  in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy,
    • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy,
    • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
    Read FDA announcement.

    Posted 5/1/2020


  • Sanofi Genzyme's CareASSIST Patient Assistance Program

    In response to COVID-19, Sanofi Genzyme is committed to helping patients. Through its CareASSIST Patient Assistance Program, eligible patients will receive assistance with access and support for their prescribed treatment. 

    Read the summary on the CareASSIST program

    Posted 4/30/2020



  • FDA Approves Niraparib for Frontine Maintenance of Advanced Ovarian Cancer

    On April 29, 2020, the U.S. Food and Drug Administration approved niraparib (Zejula, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

    Read the FDA announcement.

    Posted 4/29/2020