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Industry News Archive

  • FDA Approves Nivolumab+Ipilimumab Combo as 1st Line Treatment for Metastatic NSCLC

    On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol Myers Squibb Co.) plus ipilimumab (Yervoy, Bristol Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

    Read full FDA announcement.

    Posted May 27, 2020



  • FDA Approves Pomalidomide for Patients with AIDS-Related KS

    On May 14, 2020, the U.S. Food and Drug Administration (FDA) approved pomalidomide (Pomalyst®, Bristol Myers Squibb) capsules for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. 


    Read corporate announcement.


    Posted 5/26/2020



  • 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 the corporate press release.

    Read the Lynparza PAOLA-1 Testing Medical Policy Considerations.

    Posted 5/21/2020



  • FDA Approves Olaparib for HRR Gene-Mutated mCRPC

    On May 19, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.

    On the same day, the FDA also approved FoundationOne CDx (Foundation Medicine, Inc.) for selection of patients with mCRPC carrying HRR gene alterations and BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) for selection of patients with mCRPC carrying germline BRCA1/2 alterations as companion diagnostic devices for treatment with olaparib.  

    Read full FDA announcement.

    Posted 5/20/2020



  • 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



  • 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 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



  • 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


  • 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



  • COVID-19 Healthcare Professional Information Update

    As critical and valued partners in the healthcare community in the U.S., Pfizer wanted to share its approach to the COVID-19 pandemic and changes it is making to best address your needs and those of the patients you serve. Pfizer is taking steps to ensure supply of its medicines and help halt the spread of this disease by developing antiviral therapies and, through a partnership, a potential vaccine for the COVID-19 virus.

    Pfizer also recently announced a commitment of $40 million in medical and charitable cash grants to help address urgent needs of U.S. and global partners on the front lines of the pandemic.

    Read Pfizer's full response to COVID-19

    Posted 4/28/2020



  • BMS Patient Support Program Overview

    In light of the developing situation around COVID-19, Bristol Myers Squibb would like to share immediate action they are taking to support the health and well-being of patients, customers, and employees during this time.

    Bristol Myers Squibb is expanding its longstanding patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. The expanded program offers access to BMS medicine for free.

    Read the expanded patient support program overview.

    Posted 4/28/2020



  • BMS Patient Assistance Transportation Program

    The Community Oncology Alliance (COA) has partnered with CancerCare to provide free local transportation to patients during the COVID-19 national emergency. This program will provide free transportation for patients to and from their community oncology provider. Working with a nationwide transportation provider, practices will be able to organize free local transportation to and from appointments in clean vehicles.

    Community oncology practices must register to be part of this program. Simply fill out this form and COA will provide you with details on how to book travel for patients needing transportation.

    Posted 4/28/2020



  • CMS Re-evaluating Accelerated Payment Program; Halting Advance Payment Program

    On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. 

    CMS states that significant additional funding will continue to be available to hospitals and other healthcare providers through other programs such as the Coronavirus Aid, Relief, and Economic Security (CARES) Act (PL 116-136) and the Paycheck Protection Program and Health Care Enhancement Act (PL 116-139) for healthcare providers. The U.S. Department of Health and Human Services (HHS) is distributing these funds through the Provider Relief Fund, and these payments do not need to be repaid.

    View CMS' updated fact sheet on the Accelerated Payment Program and Advance Payment Program here.

    Posted 4/27/2020


  • Pfizer Oncology Announces Transition of IBRANCE® (palbociclib) from Capsules to Tablets

    Pfizer Oncology is pleased to announce that IBRANCE® (palbociclib) is transitioning from capsules to tablets. The new film-coated tablets will be dispensed in blister packs, whichh are designed to enable patients to track where they are in their treatment cycle. The tablet formulation is bioequivalent to the capsule formulation.

    IBRANCE® is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced, or metastatic breast cancer in combination with:

    • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or

    • fulvestrant in patients with disease progression following endocrine therapy.

    Read the trade sheet for the tablet formulation. 

    Posted 4/24/2020



  • FDA Approves KOSELUGO™ for Neurofibromatosis-1 with Plexiform Neurofibromas

    On April 10, the U.S. Food and Drug Administration (FDA) approved KOSELUGO™(selumetinib) for the treatment of children two years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas (PN) that cannot be completely removed by surgery. 

    Read corporate announcement.

    Read product fact sheet.

    Posted 4/23/2020



  • CMS Launches COVID-19 Workforce Virtual Toolkit

    On April 22, the Centers for Medicare & Medicaid Services (CMS) released a new toolkit to help state and local healthcare decision-makers in managing healthcare workforce challenges in response to the COVID-19 emergency. The online toolkit, developed by the Healthcare Resilience Task Force, includes a full suite of available resources to aid in response based on state and local needs. 

    Access the COVID-19 Workforce Virtual Tookit.

    Posted 4/22/2020



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