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Oncology Newsfeed

  • 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



  • CMS to Host 2017 MIPS Submission Q & A Sessions

    The Centers for Medicare & Medicaid Services (CMS) is hosting three “Office Hours” sessions on Merit-based Incentive Payment Systems (MIPS) submission over the next several weeks. CMS subject matter experts will answer commonly asked questions about the submission feature on qpp.cms.gov, and answer attendees’ questions live. Registrants will also be able to submit questions by email prior to the sessions.

    View “Office Hours” topics and register below. Please note that Qualified Registries, Qualified Clinical Data Registries and Web Interface Reporters should use their support calls for data submission support.

    February 14, 3:30-4:30 pm ET

    Quality Payment Program Data Submission Office Hours: Individual Eligible Clinician and Group Submission

    Register

    February 28, 3-4 pm ET

    Quality Payment Program Data Submission Office Hours: MIPS Quality Data Submission

    Register

    March 14, 3-4 pm ET

    Quality Payment Program Data Submission Office Hours: MIPS Attestation for Advancing Care Information and Improvement Activities

    Register

    Space for these sessions is limited. Register now to secure your spot. The audio portion of the sessions will be broadcast through the web. You can listen to the presentation through your computer speakers.

    For More Information

    For step-by-step instructions on how to submit MIPS data, check out this video and fact sheet. Questions about your participation status or MIPS data submission? Contact the Quality Payment Program Service Center by
    email: qpp@cms.hhs.gov.

    Posted on 2/19/2018



  • MIPS Reporting Deadlines Coming Soon

    Planning to submit data for the 2017 Merit-based Incentive Payment System (MIPS) Merit-based Incentive Payment System (MIPS) performance period? Deadlines are coming in March, and the Centers for Medicare & Medicaid Services (CMS) urges providers not to wait until the last minute to submit data.

    The two key dates are:

    If you’re not sure if you are required to report for MIPS, enter your National Provider Identifier (NPI) in the MIPS Lookup Tool to find out whether you need to report. Additionally, if you know you are in a MIPS APM or Advanced APM, you can use the APM Lookup Tool.   

    Questions about your participation status or MIPS data submission? Contact the Quality Payment Program Service Center by:

    For more information and a quality reporting timeline, visit the Quality Payment Program website

    Posted 2/8/18



  • FDA Approves Zytiga Plus Prednisone for Metastatic High-Risk Prostate Cancer

    The Janssen Pharmaceutical Companies of Johnson & Johnson on February 8, 2018, announced U.S. Food and Drug Administration (FDA) approval of a new indication for Zytiga (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). 

    Read Corporate Press Release
    Posted 2/8/18