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Oncology Newsfeed

  • FDA Consumer Information on Respiratory Illnesses Associated with Vaping Products

    The U.S. Food and Drug Administration (FDA) has announced new webpage on respiratory illnesses associated with use of vaping products.

    Both FDA and the U.S. Centers for Disease Control (CDC) are working to investigate incidents of severe respiratory illness associated with use of vaping products. 

    While federal and state health officials work to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA has some information that consumers can use to help protect themselves.

    Access the FDA information.

    Posted 9/13/2019



  • CMS Announces Support for Florida in Preparation for Hurricane Dorian

    The Centers for Medicare & Medicaid Services (CMS) Aug. 30 announced efforts underway to support Florida in response to Hurricane Dorian. Health and Human Services Secretary Alex Azar declared a public health emergency in the state. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Dorian. CMS will be waiving certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare quickly; and taking steps to ensure dialysis patients obtain critical life-saving services.

    Below are key administrative actions CMS will be taking in response to the public health emergency declared in Florida:

    Waivers and Flexibilities for Hospitals and other Healthcare Facilities:  CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will also issue a number of blanket waivers, listed on the website below, and the CMS Regional Office will grant other provider-specific requests for specific types of hospitals and other facilities in Florida. These waivers work to provide continued access to care for beneficiaries. More information is available here.

    Special Enrollment Opportunities for Hurricane Victims:  CMS will make available special enrollment periods for certain Medicare beneficiaries and individuals seeking health plans offered through the Federal Health Insurance Exchange. This gives people impacted by the hurricane the opportunity to change their Medicare health and prescription drug plans and gain access to health coverage on the Exchange if eligible for the special enrollment period. More information available here and here. 

    Disaster Preparedness Toolkit for State Medicaid Agencies:  CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. Access more information and the toolkit. 

    Dialysis Care:  CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated ahead of the storm and is working with the End Stage Renal Disease (ESRD) Network of Florida, ESRD NW7, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility, the ESRD NW hotline number, and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. The ESRD NW7 toll-free hotline is 800-826-3773 and the KCER hotline is 866-901-3773. Additional information is available on the KCER website. 

    Medical equipment and supplies replacements:  CMS will be temporarily suspending certain requirements necessary for Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.

    Suspension of Enforcement Activities:  CMS will suspend current survey and enforcement activities for healthcare facilities in Florida, but will continue to investigate allegations of immediate threat to patient health and safety.

    Ensuring Access to Care in Medicare Advantage and Part D:  During a public health emergency, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

    Posted 8/30/2019


  • USPSTF Updates Recommendation on Screening, Counseling, Testing for BRCA-related Cancer

    The U.S. Preventive Services Task Force has updated its Recommendation Statement on BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing. The full recommendation is published online in the Aug. 20 issue of JAMA.

    The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 (BRCA1/2) gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing. 

    The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations. 

    Read the Recommendation Statement on the USPSTF website.

    Posted 8/20/2019


  • FDA Approves Fedratinib for Intermediate-2 or High-Risk Myelofibrosis

    On August 16, 2019, the Food and Drug Administration approved fedratinib (Inrebic, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

    The prescribing information for fedratinib includes a Boxed Warning to advise healthcare professionals and patients about the risk of serious and fatal encephalopathy, including Wernicke’s encephalopathy. Healthcare professionals are advised to assess thiamine levels in all patients prior to starting fedratinib, periodically during treatment, and as clinically indicated. If encephalopathy is suspected, fedratinib should be immediately discontinued and parenteral thiamine initiated.

    Read FDA announcement.

    Posted 8/16/2019


  • FDA Approves Entrectinib for ROS1-Positive, Metastatic NSCLC

    Roche announced August 16 that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).

    The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

    Read corporate press release.

    8/16/2019


  • CMS Finalizes NCD for CAR T-Cell Therapy

    On August 7, the Centers for Medicare & Medicaid Services (CMS) released the finalized National Coverage Determination for FDA-approved Chimeric Antigen Receptor T-cell (CAR T-cell) Therapy. FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.  

    Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia.

    The NCD     continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

    In announcing the NCD, CMS notes that outcomes data for CAR T-cell therapy in the Medicare population are "relatively limited," and states that "CMS will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible." 

    Read the CMS Decision Memo.

    Download CMS Decision Memo.

    Posted 8/07/2019


  • New NCCN Guidelines Address Small Intestine Cancers

    On August 1, the National Comprehensive Cancer Network (NCCN) announced release of new NCCN Guidelines for Small Bowel Adenocarcinoma. These are the first clinical guidelines in the U.S. to address this rare but growing cancer type, which is sometimes associated with hereditary causes like Lynch syndrome.

    NCCN also recently released Updated NCCN Guidelines for Genetic/Familial Risk Assessment: Colorectal Cancer and Colorectal Cancer Screening, which clarify how to use genetic testing and screening to detect cancer in high-risk individuals at an earlier stage.

    Read NCCN press release. 

    Posted 8/1/2019



  • HHS Issues Plan Outlining 2 Paths for Prescription Drug Importation

    The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the importation of certain drugs originally intended for foreign markets.

    Pathway 1: A Notice of Proposed Rulemaking (NPRM) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada.

    Pathway 2: Manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. 

    Read the HHS press release.
    Read the administration's Action Plan.

    Posted 7/31/2019


  • FDA Approves Pembrolizumab for PD-L1 Positive Advanced SCC of Esophagus

    On July 31, Merck announced U.S. Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

    Read the corporate press release    .

    Posted 7/31/2019


  • FDA Approves Darolutamide for Non-metastatic Castration-resistant Prostate Cancer

    On July 30, Bayer announced U.S. Food and Drug Administration (FDA) approval of Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa was approved under the FDA's Priority Review designation.

    Read corporate press release.

    Posted 7/31/2019