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Oncology Newsfeed

  • FDA Expands Coverage of Diagnostic Testing Using NGS

    On Jan. 27, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded coverage of FDA-approved laboratory diagnostic tests that use next generation sequencing (NGS) for patients with germline, or inherited, ovarian or breast cancer. CMS also gave the Medicare Administrative Contractors (MACs) the ability to determine coverage of NGS laboratory tests for other inherited cancers.

    Read CMS Decision Memo for NGS for Medicare Beneficiaries with Advanced Cancer (CAG-00450R).

    Read CMS announcement.

    Posted 1/28/2020

  • FDA Approves Tazverik for Advanced Epithelioid Sarcoma in Patients Aged 16 Years & Older

    On Jan. 23, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults.

    Tazverik blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing.

    Read FDA announcement.

    Posted 1/24/2020

  • GAO Report Calls for More Oversight of 340B Hospital Eligibility

    A recent report from the Government Accountability Office (GAO) published Jan. 10, 2020, calls on the Health Resources and Services Administration (HRSA) to improve processes to reasonably assure that participating non-governmental hospitals meet 340B Drug Pricing Program eligibility requirements.

    The 340 Drug Pricing Program (340B Program) is administered by the U.S. Department of Health and Human Services' (HHS) Health Resources and Services Administration (HRSA). Under the 340B Program, certain hospitals and other qualified entities that care for many low-income and uninsured individuals receive discounted prices on outpatient drugs from drug manufacturers. About two-thirds of hospitals participating in the 340B Program (approximately 1,700) are non-governmental hospitals (i.e., private, nonprofit hospitals).

    The GAO makes several recommendations for achieving greater oversight of hospital eligibility. Among these, the report recommends that HRSA:

    • Implement a process to verify that all non-governmental hospitals have contracts in place, including throughout hospitals’ audit periods;
    • Amend its contract reviews to include an assessment of whether contracts meet statutory requirements;
    • Provide better guidance on contract reviews.

    HHS agreed with all of the GAO’s recommendations except the recommendation to implement a process to verify that all non-governmental hospitals have contracts in place. HHS says that HRSA does not have the resources to carry out the recommended verification process and it would over-burden the agency.

    Read the full report.
    Read GAO recommendations.

  • Update to ASCO/CAP Guideline on ER and PgR Testing in Breast Cancer

    On Jan. 13, an updated guideline for estrogen and progesterone receptor (ER/PgR) testing in breast cancer was released jointly by the College of American Pathologists (CAP) and the American Society of Clinical Oncology (ASCO). The updated guideline reaffirms much of the original guidance and includes more specific recommendations for handling and reporting cases with low ER expression. The updated guideline was posted as online early release to the Archives of Pathology & Laboratory Medicine (Jan. 13, 2020, doi: 10.5858/arpa.2019-0904-SA).

    A CAP press release highlights the following changes:
    "Cases with 1-10% of cells staining for ER expression will now be reported as ER-low positive. Pathology reports for these cases should include a recommended comment that acknowledges the more limited data on endocrine responsiveness in this group. Also in such cases, pathologists should report the status of internal controls, with a special comment for specimens that lack internal positive controls."

    The CAP press release also notes that the new guideline more clearly recommends that:
    ". . . ER be tested in cases of newly diagnosed DCIS (without invasion) to help estimate potential benefit of endocrine therapy to reduce the risk of a future breast cancer event. But, specifically, PgR testing in DCIS is optional."

    Read the CAP press release.
    Access the updated Estrogen and Progesterone Receptor Testing in Breast Cancer guideline

    Posted 1/14/2020

  • FDA Approves Avapritinib for GIST Subset

    On Jan. 9, 2020, the U.S. Food and Drug Administration (FDA) announced approval of avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keep the cancer cells from growing.

    Read the FDA approval announcement.

    Posted 1/9/2020.

  • ACS Report Finds Largest One-Year Drop in Cancer Deaths

    The American Cancer Society’s annual report on U.S. cancer statistics, released Jan. 8, announced the greatest one-year decline in deaths from cancer since 1930. From 2016 to 2017, overall deaths from cancer dropped 2.2 percent. Between 1991 and 2017, the U.S. has seen the overall cancer death rate drop 29 percent.  

    In a statement, lead study author Rebecca Siegel, MPH, attributed the record drop to improved statistics related to lung cancer. While a decrease in smoking rates has contributed to the decline, Siegel also credited recent advances in lung cancer treatment for this year's record drop. These include surgical advances, improved diagnostic screening, as well as advances in radiation therapy and anticancer therapeutics.

    The U.S. continues to see increases in new cases of certain cancers including cancers of the kidney, pancreas, liver, and oral cavity and pharynx (among non-Hispanic whites), and melanoma skin cancer.

    The American Cancer Society estimates for 2019, the U.S. saw approximately 1,762,450 cancers diagnosed.

    Read the full report.
    Read Facts & Figures 2020.

    Posted 1/9/2019

  • FDA Approves Pembrolizumab for Treatment of Subset of Bladder Cancer Patients

    On Jan. 8, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

    Read the FDA announcement.

    Posted 1/8/2020

  • FDA Approves Olaparib for Pancreatic Cancer

    On Dec. 30, 2019, AstraZeneca and Merck announced U.S. Food and Drug Administration (FDA) approval of olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

    Read the corporate press release.

    Myriad Genetics, Inc., announced Dec. 30, 2019, FDA has approved the company's BRACAnalysis CDx® for use as a companion diagnostic test by healthcare professionals to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor Lynparza® (olaparib). 

    Read the corporate press release.

    Posted 12/30/2019

  • FDA Approves Enhertu for Previously Treated Unresectable or Metastatic HER2+ Breast Cancer

    On December 20, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

    Read FDA announcement.

    Posted 12/20/2019

  • ACCC Responds to CMMI RFI on Oncology Care First Model

    On Dec. 12, 2019, the Association of Community Cancer Centers (ACCC) provided comments to the Center for Medicare and Medicaid Innovation's informal Request for Information on its potential Oncology Care First Model. Applauding CMMI for making the OCF Model voluntary and envisioning a multi-payer model, ACCC urged CMMI to:

    • make significant changes to the risk tracks for purposes of performance-based payment episodes,

    • structure the prospective payment for care management and certain other services as a supplemental payment,

    • provide more detail on the methodology for the novel therapy adjustment and ensure that the final adjustment adequately accounts for the cost of innovative and often life-saving new therapies, and

    • provide more details and future opportunities to comment on the OCF before finalizing the Model.
    Learn more and read comment letter

    Posted 12/19/2019