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Oncology Newsfeed

  • 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


  • FDA Approves Sacituzumab Govitecan-hziy in Previously-Treated Metastatic Triple Negative Breast Cancer

    On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy™) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

    Read FDA announcement.

    Read corporate press release.

    Posted 4/22/2020


  • ONC, CMS to Exercise Enforcement Discretion for Interoperability Requirements

    The Office of the National Coordinator for Health Information Technology (ONC) announced April 21 that due to the COVID-19 public health emergency, ONC will exercise its discretion in enforcing all new requirements that have compliance dates and time frames until three months after each initial compliance date or timeline identified in the ONC Cures Act Final Rule. Learn more.

    Cures Final Act Rule Enforcement Discretion Dates & Timeframes.

    CMS press release.
    CMS announcement.

    Posted 4/22/2020


  • Senate Passes Emergency Funding Package Aimed for Providers and Small Businesses

    On Tuesday, April 21, the U.S. Senate passed by voice vote a $484 billion coronavirus relief bill that includes $75 billion for providers. It is anticipated that House members will vote on the legislation on Thursday.

    Source: InsideHealthPolicy

    Posted 4/21/2020


  • FDA Approves Ibrutinib in Combination with Rituximab for CLL or SLL

    On April 21, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

    This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. 

    Read the FDA announcement.

    Posted 4/21/2020



  • CMS Issues Guidance for Some Facilities to Re-Start Non-Essential Services

    On April 19, the Centers for Medicare & Medicaid Services (CMS) released guidance for facilities in areas with a low, or relatively low and stable incidence of COVID-19, to resume providing non-emergent, non-COVID-19 healthcare services. Many non-essential surgeries and procedures have been curtailed since March 18 when the agency recommended that facilities limit non-essential care to preserve personal protective equipment (PPE) and prepare for potential surge areas.

    The CMS guidance references the White House plan for Opening Up America, released on Friday, April 17. The agency's guidance titled, Opening Up America Again, Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I, notes that "if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I."

    Access the CMS guidance.

    Posted 4/20/2020
     


  • FDA Approves Pemigatinib for Certain Unresectable Advanced Cholangiocarcinomas

    On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

    The FDA also approved the FoundationOne® CDX (Foundation Medicine, Inc.)  as a companion diagnostic for patient selection.

    Read FDA announcement.

    Posted 4/20/2020



  • FDA Approves Tucatinib in Combination for Advanced HER2-Positive Breast Cancer

    On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.

    Read FDA announcement.


    Posted 4/17/2020


  • White House Guidance Suggests Phased-In Approach for Easing COVID-19 Restrictions

    On Thursday, April 16, the White House released guidance for a phased-in approach for easing social distancing and stay-at-home restrictions instituted in response to the novel coronavirus-19. In a call with state governors on Thursday, President Trump said that each state can determine its own plan for reopening, and that the White House three-phase plan titled, "Guidelines: Opening Up America Again," was intended to serve as general guidance and was not a mandate.

    Some state governors are starting to lay out forward-looking scenarios. However, state governors remain concerned about relaxing stay-at-home restrictions too early, before there is the capacity to clearly identify who is sick and where.


    Posted 4/17/2020


  • FDA Approves Eltrombopag 25-mg Powder for Suspension Package Size

    Novartis Pharmaceuticals Corporation has announced that the US Food and Drug Administration approved Promacta® (eltrombopag) 25-mg powder for suspension package size on March 23, 2020.

    Read corporate announcement.


    4/17/2020