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Oncology Newsfeed

  • FDA Issues EUA for Moderna's COVID-19 Vaccine

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The FDA has determined that the vaccine has met the statutory criteria for issuance of an EUA.

     

    Read the FDA announcement.

    Posted 12/18/2020



  • FDA Approves Amgen's Rituximab Biosimilar

    On December 17, 2020, the U.S. Food and Drug Administration (FDA) approved Amgen's rituximab biosimilar Riabni™ (rituximab-arrx), which references Rituxan® (rituximab) and is indicated for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

    Read Amgen's announcement.

    Posted 12/18/2020



  • FDA Approves Margetuximab for Patients with Metastatic HER2+ Breast Cancer

    On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

    Read the FDA announcement.

    Read MacroGenics' announcement.

    Posted 12/17/2020



  • FDA Issues EUA for First COVID-19 Vaccine

    On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows Pfizer and BioNTech's COVID-19 vaccine to be distributed in the United States. The FDA has determined that the vaccine has met the statutory criteria for issuance of an EUA.

     

    For more information on the FDA's emergency use authorization, read the FDA announcement.

     

    Posted 12/12/20



  • CMS Announces "PFS Final Rule: Understanding 4 Key Topics Call"

    The Centers for Medicare & Medicaid Services (CMS) announces its "Physician Fee Schedule Final Rule: Understanding 4 Key Topics Call" scheduled for December 10, 2020. During this call, CMS experts will briefly cover provisions from the final rule and address participants' questions.

    The target audience for this call is: Medicare Part B Fee-for-Service clinicians; office managers and administrators; state and national associations that represent health care providers; and other stakeholders.

    You can register for this event on the CMS website. CMS encourages participants to review the final rule prior to the call.

    Posted 12/03/2020



  • CMS Announces RO Model Updates

    The Centers for Medicare & Medicaid Services (CMS) announced its intent to delay the Radiation Oncology (RO) Model to July 1, 2021. The delay is included in the 2021 Hospital Outpatient Prospective Payment (OPPS) Final Rule (CMS-1736-FC) as an interim final rule with a comment period.

    Due to the delay, the following changes have been made to the RO Model:

    • The first performance year (PY) will be from July 1 to Dec. 21, 2021.
    • The model performance period will be 4.5 years.
    • CMS expects the Model to qualify as an Advanced Alternative Payment Model (APM) and a Merit-Based Incentive Payment System (MIPS) under the CMS Quality Payment Program (QPP) beginning in the PY2.
    • Certified Electronic Health Record Technology will be a requirement starting in PY2.
    • The individual practitioner list will still be required in PY1, but it will only be used for QPP in PY1 to assign an automatic 50 percent score for the Improvement Activity performance category in MIPS for RO participants.
    • RO participants must, beginning in PY2, collect quality measures data from Jan. 1, 2022, through Dec. 31, 2022, and submit in March 2023.
    • The collection period for clinical data elements will begin on Jan. 1, 2022. The first submission of the clinical data elements for Jan. 1, 2022, through June 30, 2022, will be due in July 2022.
    • A CMS-approved contractor will administer the CAHPS® Cancer Care Survey for Radiation Therapy beginning in October 2021 instead of April 2021.

    An updated version of the RO Model FAQs to reflect these changes is available.

    RO Model Billing Webinar Update
    This webinar has also been postponed to Jan. 13, 2021. Call in information for this webinar can be found here.

    For any questions not answered in this update, you can reach out via email to CMS at: radiationtherapy@cms.hhs.gov. Additional information about the RO Model, including all changes, can be found on its website.

    Posted 12/3/2020

     



  • FDA Approves Pralsetinib for RET-Altered Thyroid Cancers

    On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved pralsetinib for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

    Read the FDA announcement.

    Read Genentech's announcement.

    Posted 12/2/2020



  • FDA Approves PSMA-Targeted PET Imaging Drug for Prostate Cancer

    On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved Gallium 68 PSMA-11 (Ga 68 PSMA-11)—the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

    Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an intravenous injection.

    Read the FDA announcement.

    Posted 12/1/2020



  • Moderna Announces EUA Request to FDA for COVID-19 Vaccine Candidate

    On November 30, 2020, Moderna announced that it has submitted an emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate mRNA-1273. Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17. 

     

    The company shared that the primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 based on 196 cases confirms the high efficacy observed at the first interim analysis. The point estimate performed indicates a vaccine efficacy of 94.1 percent. Efficacy was consistent across age, race, ethnicity, and gender demographics.

     

    Moderna anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an EUA is granted.

    Read Moderna's press release. You can find out more on Moderna's COVID-19 vaccine candidate from the Wall Street Journal, New York Times, and Bloomberg.

    Posted 12/1/2020



  • CMS Announces Resources + Office Hours for RO Model Participants

    The Centers for Medicare & Medicaid Services (CMS) has released resources and reminders to help those participating in the Radiation Oncology (RO) Model. These resources include help with accessing and navigating the Radiation Oncology Administrative Portal (ROAP).

    Upcoming Changes to the ROAP:

    • Access to multiple RO Model IDs
    • Low volume opt-out
    • Ability to edit your profile information.

    If you haven't already done so, CMS encourages you to register for ROAP as soon as possible. To register for ROAP, you will need your Model ID, Taxpayer Identification Number (TIN) for physician group practices and freestanding radiation therapy centers or CMS Certification Number (CCN) for Hospital Outpatient Departments, first name, last name, and email address of the designated primary contact in the appropriate fields.

    If you do not know your Model ID, please contact the CMS Helpdesk (1.888.734.6433, option 5). Hospital Outpatient Departments should email or call with their CMS Certification Number (CCN), so it can provide the correct Model ID; physician group practices and freestanding radiation therapy centers should call the Helpdesk with their practice’s Taxpayer Identification Number (TIN) to retrieve the correct Model ID.

    ROAP Office Hours
    RO participants can call into standing office hours that have been set up for troubleshooting ROAP login issues. Office hour dates and times include:

    • Tuesday, December 1 at 12:00 PM EST
    • Thursday, December 3 at 12:00 PM EST

    More dates are to be determined after Dec. 3, 2020. To join an office hour, join the Zoom meeting by following the link or by entering the Meeting ID (160 189 1276) and password (881584) on Zoom.

    For additional information about the RO Model, please visit its website. Or read the ROAP User Manual and ROAP FAQs.

    Posted 12/1/2020