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Oncology Newsfeed

  • President's Cancer Panel Urges Collaboration to Better Align Drug Prices with Value

    A report from the President's Cancer Panel released March 13 calls on stakeholders from all segments of oncology to join together to "maximize the value and affordability of cancer drug treatment" while continuing to support investment in research to propel future innovations.

    "Cancer patients should not have to choose between paying for their medications or paying their mortgages. For so many, it is truly a matter of life and death," said Barbara K. Rimer, DrPH, chair of the President's Cancer Panel, in a statement. "This is a national imperative that will not be solved by any one sector working alone."

    The report, Promoting Value, Affordability, and Innovation in Cancer Drug Treatment, urges action informed by three guiding principles:

    • Cancer drug prices should be aligned with their value to patients;
    • All patients should have affordable access to appropriate cancer drugs; and
    • Investments in science are essential to drive future innovation.

    The President's Cancer Panel, established by the National Cancer Act of 1971, is an independent entity charged with monitoring the National Cancer Program and reporting to the President on any barriers to its execution. Learn more about the Panel's role and members.

    Read the Executive Summary.
    Read the Recommendations at a Glance.

    Posted 3/13/18


  • ASTRO Issues Clinical Guideline for WBRT

    The American Society for Radiation Oncology (ASTRO) today issued a new clinical guideline for the use of whole breast radiation therapy (WBRT) for breast cancer that expands the population of patients recommended to receive accelerated treatment known as hypofractionated therapy.

    Reflecting current evidence from clinical trials and large cohort studies, the new guideline recommends hypofractionated WBI for breast cancer patients regardless of age, tumor stage, and whether they have received chemotherapy.

    The guideline provides clinical guidance for dosing, planning and delivering whole breast irradiation (WBI) with or without an additional "boost" of radiation therapy to the tumor bed. Full recommendations and supporting evidence are provided in the guideline.

    Read the ASTRO press release.

    Posted 3/13/18


  • Trump Administration Announces MyHealthEData Initiative

    Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma has announced the administration's new MyHealthEData, an initiative that aims to give Americans more complete access to their healthcare data. She made the announcement in an address on March 6, 2018, at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference in Las Vegas. The government-wide initiative is being led by the White House Office of American Innovation with participation from the Department of Health and Human Services, including CMS; Office of the National Coordinator for Health Information Technology (ONC); the National Institutes of Health; and the Department of Veterans Affairs. 

    As part of MyHealthEData announcement, CMS also announced that the agency intends to "overhaul" the EHR Incentive Programs to "refocus the programs on interoperability and to reduce the time and cost required" for providers to meet requirements. 

    In her remarks, Administrator Verma also described Medicare's Blue Button 2.0 - a tool that would allow Medicare beneficiaries to access and their personal health data in a "universal digital format."  

    As part of this initiative, the administration is also calling on healthcare insurers to follow suit and give patients access to their claims data in a digital format. 

    The administration is still developing a timeline for the initiative, Verma said in an interview with Bloomberg BNA. 

    Read the CMS press release.
    Read the CMS fact sheet. 

    Posted 3/7/18



  • FDA Authorizes First Direct-to-Consumer Test For 3 BRCA Mutations

    On March 6, 2018, the U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.

    The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The test only detects three out of more than 1,000 known BRCA mutations. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.

    The FDA press release states:

    "Consumers and healthcare professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries. Such decisions require confirmatory testing and genetic counseling. The test also does not provide information on a person’s overall risk of developing any type of cancer. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor."

    Read the FDA announcement.

    Posted 3/6/2018



  • FDA Approves Abemaciclib for HR+/HER2- Advanced Breast Cancer

    On February 26, 2018, the U.S. Food and Drug Administration FDA) approved abemaciclib (Verzenio™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

    Read FDA announcement    .

    Posted 2/27/2018


  • FDA Approves Durvalumab for Stage III Unresectable NSCLC

    On September 16, 2018, the U.S. Food and Drug Administration (FDA) approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).


    Read the FDA announcement    .

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  • FDA Approves Erleada for Certain Prostate Cancer Patients

    On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.

    Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth. 

    The sponsor for Erleada is the first participant in the FDA’s recently-announced Clinical Data Summary Pilot Program, an effort to provide stakeholders with more usable information on the clinical evidence supporting drug product approvals and more transparency into the FDA’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page.

    Read FDA press release.

    Posted 2/14/2018


  • ASCO & NCCN Release Guidance on Management of Immunotherapy Side Effects

    On February 14, 2018, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) jointly announced release of guidance on managing side effects of immunotherapy with immune checkpoint inhibitors. The organizations note that these guidelines pertain only to immune checkpoint inhibitors, not to other types of immunotherapy. 

    To date, several checkpoint inhibitor immunotherapies have been approved by the U.S. Food and Drug Administration (FDA) for treatment of a number of cancer types, including melanoma, Hodgkin lymphoma, and lung, liver, kidney, and bladder cancer. In the rapidly evolving cancer immunotherapy landscape, the number of agents, new indications, and combination therapies continues to grow.

    In a joint news release, ASCO and NCCN briefly outline the guideline development process, which included convening multidisciplinary panels with representation from medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, and nursing, as well as patient advocacy experts. The clinical recommendations were based on a systematic literature review and an informal consensus process.  

    "The Management of Immune-related Adverse Events in Patients Treated with Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline," was published online February 14, 2018, in the Journal of Clinical Oncology. Read the article.

    NCCN Guidelines® for Management of Immunotherapy-Related Toxicities were published online at NCCN.org on February 14, 2018.

    ASCO and NCCN welcome feedback on their guidelines from oncologists, practitioners, and patients through the ASCO Guidelines Wiki or via the NCCN submission form at NCCN.org.



  • Proceedings from NASEM Workshop on Weight Management & Exercise Across Cancer Continuum Available

    The National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine (NASEM) has announced that the final Proceedings from its public workshop, Incorporating Weight Management and Physical Activity Throughout the Cancer Care Continuum are now available.

    The workshop, held February 13-14, 2017, in Washington, D.C., highlighted the current evidence base, gaps in knowledge, and research needs on the associations among obesity, physical activity, weight management, and health outcomes for cancer survivors. Presentations and discussions also examined the effectiveness of interventions for promoting physical activity and weight management among people living with or beyond cancer, as well as opportunities and challenges for providing weight management and physical activity interventions to cancer survivors.

    Download proceedings.

    Posted 2/12/18



  • White House Issues Report on Reforming Drug Pricing

    A report from the White House Council of Economic Advisors released on February 9 asserts the need for major policy changes at the federal level in order to lower drug prices, including reforms impacting the FDA and changes to Medicare and Medicaid.

    Read "Reforming Biopharmaceutical Pricing at Home and Abroad."

    Posted 2/12/2018