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Oncology Newsfeed

  • FDA Approves Pembrolizumab for Metastatic SCLC

    On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

    Read FDA announcement.

    Posted 6/18/2019


  • FDA Approves Biosimilar Trastuzumab-anns for All Approved Herceptin Indications

    On June 13, 2019, Amgen and Allergan plc announced the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

    Read corporate press release.

    Posted 6/14/2019


  • ACCC Joins In Comment Letter on Medicare NGS NCD

    The Association of Community Cancer Centers (ACCC) has joined with oncology stakeholder organizations in a comment letter to the Centers for Medicare & Medicaid Services (CMS) on National Coverage Determination (NCD) 90.2 for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R).

    Section 90.2 of NCD describes conditions of coverage for NGS. The section is being interpreted to apply to NGS tests for somatic and germline mutations. Additionally, Section 90.2 of the NCD states criteria that patients must meet to qualify for NGS testing, and stipulates specific requirements that the diagnostic laboratory test using NGS must meet.

    The comment letter to CMS cites specific concerns regarding the potentially deleterious effect of the Section 90.2 NCD on access to germline testing. The stakeholder letter recommends to CMS "that NCD 90.2 be revised to indicate that NGS-based germline genetic tests are exempt from the policy. This National Coverage Determination should specifically apply to somatic mutation testing and be renamed:

    National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) for Somatic."


    Read the comment letter.


  • ACCC Joins In Support for S. 946, Legislation to Improve Access to Clinical Trials

    The Association of Community Cancer Centers (ACCC) joined the American Cancer Society Cancer Action Network, the American Lung Association, the American Society of Clinical Oncology, the Cancer Support Community, and a number of other oncology clinical, professional, and patient advocacy organizations in a June 6, letter of support for S. 946, the Henrietta Lacks Enhancing Cancer Research Act of 2019.

    The legislation is aimed at eliminating barriers in patient access to cancer clinical trials, with a special emphasis on decreasing disparities in cancer clinical trials. 

    Read the letter.



  • FDA Approves Polatuzumab Vedotin-piiq + BR for Diffuse Large B-Cell Lymphoma

    On June 10, Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to polatuzumab vedotin-piiq (PolivyTM) in combination with bendamustine plus rituximab (BR) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.

    Read the Genentech press release.

    Posted 6/10/2019


  • MA Prior Auth Bill Would Simplify Process; Increase Transparency

    On Wednesday, June 5, a bipartisan group of legislators introduced the “Improving Seniors’ Timely Access to Care Act of 2019” (H.R. 3107).  The bill would require the Centers for Medicare & Medicaid Services (CMS) to regulate the use of prior authorizations by Medicare Advantage (MA) plans in order to streamline the current MA prior authorization system.

    The bill also calls for increased transparency in the prior authorization process and would require MA plans to report the extent of their prior authorization use to CMS, as well as their rate of approvals or denials. 

    Cosponsors of the bipartisan bill include Rep. Roger Marshall, MD (R-Kan.), Rep. Mike Kelly (R-Pa.), Rep. Ami Bera, MD (D-Calif.), and Rep. Suzan DelBene (D-Wash.).

    Posted 6/6/2019




  • CMS Issues RFI on Reducing Administrative Burden

    On June 6, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) seeking new ideas from the public to continue the administration's Patients over Paperwork initiative. The RFI will be published in the Federal Register on June 11. 

    The RFI invites patients and their families, the medical community, and other healthcare stakeholders to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and healthcare system’s resources from paperwork to high-quality care that improves patient health.

    According to the agency's press release, CMS is seeking innovative ideas to relieve burden and improve:

    • Reporting and documentation requirements
    • Coding and documentation requirements for Medicare or Medicaid payment
    • Prior authorization procedures
    • Policies and requirements for rural providers, clinicians, and beneficiaries
    • Policies and requirements for dually enrolled (i.e., Medicare and Medicaid) beneficiaries
    • Beneficiary enrollment and eligibility determination
    • CMS processes for issuing regulations and policies

    Comments must be submitted by August 12, 2019.

    Posted 6/6/2019

     


  • Annual Cancer Report to the Nation: Overall Cancer Mortality Decline Continues

    The Annual Report to the Nation on the Status of Cancer released on May 30, finds that for all cancer sites combined the overall cancer death rate continued to decrease in U.S. men, women, and children from 1999 to 2016. In men, the overall cancer incidence rates decreased from 2008 to 2015, after increasing from 1999 to 2008. Cancer incidence rates were stable in women from 1999 to 2015.

    This year's report includes a special section on cancer rates and trends in adults ages 20 to 49.  Among adults 20-49 years, researchers report that incidence and death rates were lower among men than women. The most common cancers in this age group were:
    • Breast, thyroid, and melanoma of the skin for women, with breast cancer far exceeding any of the other cancers; and
    • Colorectal, testicular, and melanoma of the skin for men.
    The report is jointly issued by the Centers for Disease Control and Prevention (CDC), the North American Association of Central Cancer Registries (NAACCR), the American Cancer Society (ACS), and the National Cancer Institute (NCI).

    Access highlights and the full report on the CDC website here.

    Read NCI press release here.

    Posted 5/30/2019


  • FDA Approves Lenalidomide in Combination for Follicular and Marginal Zone Lymphoma

    On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

    Read FDA announcement.

    Posted 5/28/2019


  • FDA Approves Alpelisib for Metastatic Breast Cancer

    On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

    Read FDA announcement
    .

    Posted 5/28/2019