Industry News

  • 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 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



  • Genentech's Response to COVID-19

    Genentech takes the health and safety of its patients, customers, employees, and local communities very seriously, and are actively responding to the global COVID-19 pandemic. Genentech knows that needs will continue to emerge over the coming weeks and months, and they are closely monitoring and evaluating the situation as it evolves.

    For more information on Genentech's response to COVID-19, please visit its website

    Posted 4/28/2020




1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
wvosinfo.com
Email Us