Industry News Archive

  • 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



  • 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 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



  • 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


  • FDA Approves Tukysa™ for Patients with HER2-Positive Metastatic Breast Cancer

    On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa™(tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2+ breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

    Read FDA announcement.

    Read full prescribing information

    Posted 4/29/2020

     



  • Merck Broadens Patient Support and Assistance Programs as Part of Overall COVID-19 Relief Efforts

    In response to the COVID-19 pandemic, Merck is focused on protecting the safety of its employees and their families, ensuring that its supply of medicines and vaccines reach its patients, contributing its scientific expertise to the development of antiviral approaches, and supporting healthcare providers and their communities. 

    Read the press release for more information on Merck's response to COVID-19.

    Posted 4/29/2020



  • How Pfizer Oncology Together Is Addressing Patient Needs

    Pfizer recognizes the strain that the COVID-19 pandemic is placing on patients and healthcare providers around the world, and is working with governments, international NGOs, and U.S.-based not-for profit organizations to respond to this pandemic by donating much needed medications and vaccines and working to support front-line health workers.

    Read Pfizer's full response to COVID-19

    Posted 4/28/2020




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