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Oncology Newsfeed

  • FOA: Optimizing Management & Outcomes for Survivors Moving Into Follow-Up Care

    The National Institutes of Health (NIH)/National Cancer Institute (NCI) have announced a funding opportunity RFA-CA-19-035, titled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-Up Care (RO1 Clinical Trial Required)"

    The Funding Opportunity Announcement (FOA) solicits applications that develop and test models of care for adult survivors of cancer who are transitioning from active treatment to follow-up care. Through this FOA, the NCI intends to support multi-level interventions that enhance communication, collaboration, and coordination among oncology and non-oncology providers to improve cancer survivor outcomes.

    Interventions that focus on the needs of racial/ethnic minority or medically underserved adult survivors and/or those receiving care in community settings (including, but not limited to, community-based cancer centers) are not required but strongly encouraged. NCI seeks to fund applications that represent a broad spectrum of cancer survivors (e.g., variability in demographics, cancer type, clinical characteristics) and care delivery settings (e.g., community settings, integrated healthcare settings).

    KEY DATES 

    Open Date (Earliest Submission Date): May 28, 2019

    Letter of Intent Due Date(s): 30 days prior to the application due date

    Application Due Date(s): June 28, 2019, by 5:00 PM local time of applicant organization.

    DATE FOR PRE-APPLICATION WEBINAR for RFA-CA-19-035
    May 3, 2019
    1:00 PM - 2:00 PM (ET)  

    On Friday, May 3, 2019 from 1:00 - 2:00 PM (ET), NCI will hold a pre-application webinar for RFA-CA-19-035 entitled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-up Care (R01 Clinical Trial Required)."

    NCI staff members involved in this FOA will provide orientation and technical assistance to potential applicants to the above-referenced FOA by explaining the goals and objectives for the proposed FOA and answer questions from webinar attendees. Potential applicants are encouraged to submit their questions to NCIHDRP@mail.nih.gov by 12 pm ET on May 1, 2019.

    To join the webinar, pre-registration is required through Webex. Specific webinar information will be provided upon registration.

    Posted 4/17/19



  • ASCO and ASH Updated Guidelines for Managing Biosimilar ESAs

    The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have issued an updated practice guideline on the use of erythropoiesis-stimulating agents (ESAs) in cancer care, in which they state that the available literature suggests that biosimilars of epoetin alfa have similar efficacy and safety to reference agents. The update also suggests that both biosimilars and their references may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent.

    Read the ASCO and ASH press release here.
    Read the updated ESA guideline here.

    Posted 4/17/2019


  • FDA Approves Erdafitinib for Metastatic Urothelial Carcinoma

    On April 12, the Food and Drug Administration granted accelerated approval to erdafitinib (Balversa, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

    The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication.

    Read the full FDA press release here.

    Posted 4/12/2019


  • FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment

    On April 11, 2019, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.

    Read the FDA press release here.

    Posted 4/12/2019


  • FDA Expands Palbociclib Use to Include Male Breast Cancer Patients

    On April 4, the U.S. Food and Drug Administration extended the indication of palbociclib (Ibrance, Pfizer Inc.) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

    Read the full FDA press release here.

    Posted 4/5/2019


  • FDA Proposes Policy Changes to Update Mammography Services

    The U.S. Food and Drug Administration issued a proposed rule on March 27 that would make amendments to the regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 that seek to improve the quality of mammography services. The proposed rule would expand the information mammography facilities are required to provide to patients and healthcare professionals to allow for more informed medical decision-making, the agency said in a statement. It also modernizes mammography quality stands and strengthens the FDA’s ability to enforce regulations that apply to the safety and quality of mammography services.

    Under the proposed rule, breast density information would be added to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals.

    The amendments would also expand the information provided to healthcare professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified.

    Under the proposed regulations, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications, the agency said.

    The proposed rule will be open for public comment for 90 days after publication.

    Read the FDA press release.
    View the proposed rule.

    Posted 3/27/2019



  • FDA Approves Atezolizumab for Small Cell Lung Cancer

    On March 19, the FDA approved atezolizumab (Tecentriq®, Genentech) in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

    Read the Roche press release here.
    Read the FDA press release here.
    Download the Tecentriq ES-SCLC Day 1 Letter here.

    Posted 3/19/2019


  • CMS Updates Drug Dashboards with Drug Pricing and Spending

    On March 14, the Centers for Medicare & Medicaid Services (CMS) updated its Drug Spending Dashboards with data for 2017. The dashboards add information on manufacturers that are responsible for price increases and includes pricing and spending data for drugs across Medicare Parts B and D and Medicaid.

    The dashboards focus on average spending per dosage unit for prescription drugs paid under Medicare Parts B and D and Medicaid, and tracks the change in average spending per dosage unit over time. Information is also provided on drug uses and clinical indications, so patients and physicians can compare the list prices of different medications for a given condition.

    In 2017, total gross spending on prescription drugs was $154.9 billion in Medicare Part D, $30.4 billion in Part B, and $67.6 billion in Medicaid.

    Click here to access the CMS Drug Spending Dashboards.

    Posted 3/14/2019


  • NCI Director Norman Sharpless Appointed Acting Commissioner of FDA

    On March 12, Health and Human Services Secretary Alex Azar told Congress that Norman "Ned" Sharpless, director of the National Cancer Institute (NCI), will become acting commissioner of the Food and Drug Administration (FDA), succeeding Scott Gottlieb. Gottlieb announced his April departure in the first week of March.

    Doug Lowy, current NCI Deputy Director, will serve as acting director of the NCI upon Sharpless' transition to the FDA.

    Read news coverage from STAT here.

    Posted 3/12/2019


  • FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin

    On March 11, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to Herceptin, for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

    Read the Pfizer press release here.

    Posted 3/12/2019