Industry News

  • FDA Approves Niraparib for HRD-positive Advanced Ovarian Cancer

    On October 23, 2019, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.

    The FDA also approved the Myriad myChoice CDx test for determination of tumor HRD status to select patients for niraparib.

    Read the FDA announcement.

    Access information on FDA-approved test for detection of deleterious or suspected deleterious BRCA mutation and/or genomic instability for this indication. 


    Posted 10/24/2019


  • NAM Issues Report on Systems Approach to Supporting Clinician Well-Being

    The National Academy of Medicine (NAM) has released a consensus study, Taking Action Against Clinician Burnout: A Systems Approach to Supporting Professional Well-Being, that is a call to action for healthcare organizations and educational institutions training health professionals, government, and industry to significantly improve clinical work and educational environments for all disciplines "to prevent and mitigate clinician burnout and foster professional well-being for the overall health of clinicians, patients, and the nation."

    The report sets out six goals and recommended system-wide actions to speed progress on burnout prevention and mitigation:

    1. Create positive work environments work that prevent and reduce burnout, foster professional well-being, and support quality care.
    2. Create positive learning environments that prevent and reduce burnout, foster professional well-being, and support quality care.
    3. Reduce administrative burden on clinicians that stem from a host of sources including legislation, policy, and an increasing requirements of accrediting and standard-setting entities.
    4. Optimize the use of technology to support clinicians in providing high-quality care.
    5. Provide support to clinicians and learners to alleviate symptoms of burnout.
    6. Invest in research on clinician professional well-being.

    Read the report recommendations.
    Read report highlights.
    Access the full report.

    Posted 10/23/2019


  • FDA Approves Daratumumab in Combination for Frontline Multiple Myeloma

    On September 26, 2019, the U.S. Food and Drug Administration (FDA)  approved daratumumab (Darzalex, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).

    Read FDA announcement.

    Posted 9/26/2019


  • With Project Orbis Collaboration, FDA Approves New Treatment for Endometrial Cancer

    On September 17, the U.S. Food and Drug Administration (FDA) announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE).  Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.

    As part of Project Orbis, in conjunction with decisions by the Australian Therapeutic Goods Administration (TGA) and Health Canada, the FDA today granted accelerated approval to Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. Collaboration among international regulators through Project Orbis allowed for simultaneous decisions in all three countries.

    Read FDA announcement on Project Orbis.

    Read more on FDA approval of lenvatinib in combination with pembrolizumab for certain patients with advanced endometrial carcinoma.

    Posted 9/17/2019


  • 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 Grants Acalabrutinib (Calquence) Breakthrough Therapy Designation

    AstraZeneca announced August 14 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to acalabrutinib (Calquence) for chronic lymphocytic leukemia (CLL).

    The FDA granted the designation as a monotherapy treatment for adult patients with the disease, based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials, which will serve as the foundation for regulatory submissions later this year.

    FDA Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically significant endpoint over currently available medicines. Use of acalabrutinib in adult patients with CLL is not yet FDA-approved.

    Read press release.

    Posted 8/15/2019



  • 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


  • 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


  • CMS Releases Proposed 2020 OPPS and PFS Rules

    On Monday, July 29, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) proposed rule and the CY 2020 Physician Fee Schedule (PFS) and Quality Payment Program proposed rule.

    CMS states that the OPPS proposed rule puts forward price transparency requirements that will increase competition among all hospitals by requiring them to make pricing information publicly available.

    According the agency, the policy changes included under the proposed 2020 PFS rule align with the administration's aims to reduce providers' paperwork burden, remove unnecessary reporting measures, and reward clinicians for time spent with patients.

    The ACCC policy team is currently reviewing both proposed rules and will provide a more in-depth summary for ACCC members shortly.

    Posted 7/29/2019




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