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Oncology Newsfeed

  • FDA Approves Atezolizumab Plus Nab-paclitaxel for TNBC

    On March 8, the FDA approved atezolizumab (Tecentriq, Genentech Inc.) plus nab-paclitaxel (Abraxane, Celgene) for the frontline treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC).

    Read OncLive news coverage here    .

    Posted 3/8/2019


  • CMS Seeks Input on Eliminating Barriers to Sale of Health Insurance Across State Lines

    In a March 6 press release, the Centers for Medicare & Medicaid Services (CMS) announced that the agency's issuance of a request for information (RFI) soliciting recommendations on "how to eliminate regulatory, operational and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines."

    The press release states that the RFI builds on President Trump’s October 12, 2017, Executive Order, “Promoting Healthcare Choice and Competition Across the United States” instructs the administration to facilitate the purchase of health insurance coverage across state lines.

    The RFI will be open for public comment for 60 days.

    View the RFI here.

    Posted 3/6/2019


  • FDA Approves Trastuzumab and Hyaluronidase-oysk for Breast Cancer

    On February 28, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech Inc.) for the treatment of HER2-overexpressing breast cancer.


  • FDA Approves Trifluridine and Tipiracil for Gastric/GEJ Adenocarcinoma

    On February 25, the U.S. Food and Drug Administration approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

    Read the Taiho Oncology press release here.

    Posted 2/25/2019


  • FDA Approves Pembrolizumab for Melanoma

    On February 15, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

    Read the FDA press release here.

    Posted 2/19/2019


  • ASBS Recommends Genetic Testing for All Breast Cancer Patients

    On February 14, the American Society of Breast Surgeons (ASBS) released a consensus guideline advising that genetic testing should be made available to all patients diagnosed with breast cancer, including patients who had previously been tested. ASBS developed this recommendation because it believes current guidelines regarding genetic testing for breast cancer to be too restrictive.

    ASBS also recommended that genetic testing should be made available to patients without a history of breast cancer who meet NCCN guidelines.

    Read the ASBS consensus guideline here.

    Posted 2/15/2019


  • CMS Releases Proposed NCD for CAR T-cell Therapy

    On Friday, February 15, the Center for Medicare & Medicaid Services (CMS) released a proposed national coverage determination (NCD) to provide nationwide consistency in coverage of FDA-approved CAR T-cell therapy under “Coverage with Evidence Development” (CED). Currently, nationwide coverage policy is not available for approved CAR-T therapies, and it has been covered at the discretion of local Medicare Administration Contractors (MACs) until now.

    With this proposed NCD, CMS would require Medicare to cover the therapy when offered to patients “in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.” Information generated from these registries would aid CMS in identification of future patients for CAR-T therapies and better inform future coverage determinations in which the therapy could be covered “with no registry or trial requirement.”

    Read ACCC's summary of the proposed NCD for CAR-T therapies here [log in required].

    Posted 2/15/2019
    Updated 2/28/2019


  • ACCC Joins Groups Expressing Concerns Over CMS' Interpretation of NCD for NGS

    The Association of Community Cancer Centers (ACCC) joined with more than 60 organizations in a January 31, 2019, letter to CMS Administrator Seema Verma expressing concern over recent developments in the agency's interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.

    An overarching concern is that, although the NCD was requested for a somatic-based test, the new interpretation will result in Medicare Administrative Contractors (MACs) applying the NCD's terms to both somatic and germline NGS-based testing for patients with cancer. As a result, patient access to medically necessary and relevant testing of germline mutations in patients with cancer would be restricted, as would NGS-based testing (both somatic and germline) for Medicare beneficiaries with early-stage cancer.

    Read the Letter.

    Posted 1/4/2019


  • HHS Proposes Rule to End Middleman Drug Pricing Rebates

    On January 31, Health and Human Services Secretary Alex Azar proposed a rule to remove safe harbor protections for drug rebates paid by manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans, and Medicaid managed care organizations. Through the removal of these protections, HHS and the Trump Administration continue their attempts to lower prescription drug prices and out-of-pocket costs. The proposal would also create new safe harbor protection for fixed fee service arrangements between manufacturers and PBMs. 

    Read the proposed rule here. Read the HHS press release here and the HHS fact sheet here.

    Posted 2/1/2019



  • FDA Approves Pemetrexed for Metastatic NSCLC

    On January 31, the U.S. Food and Drug Administration (FDA) approved pemetrexed for injection (Alimta, Eli Lilly and Company) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

    Read the Eli Lilly and Company press release here.

    Posted 1/31/2019