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Oncology Newsfeed

  • FDA Updates Prescribing Information for Keytruda and Tecentriq

    On August 16, 2018, the Food and Drug Administration updated the prescribing information for pembrolizumab (Keytruda, Merck & Co., Inc.) and atezolizumab (Tecentriq, Genentech, Inc.) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq.

    On August 16, 2018, the FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America, Inc.) as a companion diagnostic to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda. The 22C3 assay determines PD-L1 expression by using a combined positive score (CPS) assessing PD-L1 staining in tumor and immune cells.

    On July 2, 2018, the FDA approved the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic test to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Tecentriq. The SP142 assay determines PD L1 expression in immune cells.

    Read the full FDA announcement here.

    Posted 8/20/2018

  • FDA Approves Nivolumab for Previously Treated SCLC Patients

    On August 17, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR).

    Read the BMS press release here.
    Read the FDA announcement here.

    Posted 8/17/2018

  • FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

    On August 16, 2018, the Food and Drug Administration approved lenvatinib  (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC. The trial demonstrated that lenvatinib was non-inferior but not statistically superior to sorafenib for overall survival.

    Read the full FDA press release here.

    Posted 8/17/2018

  • HealthWell Foundation Opens Fund for Gastric Cancer Patients

    The HealthWell Foundation has opened a new fund to provide copayment and premium assistance to Medicare patients living with gastric cancer. Through the new fund, HealthWell will provide up to $10,000 in financial assistance for a 12-month grant to eligible patients who have annual household incomes up to 400 percent of the federal poverty level.

    To determine eligibility and apply for financial assistance, visit HealthWell's Gastric Cancer Fund page.

    Read the full HealthWell press release here

  • NCCN Publishes Guidelines for Rare Cancers Associated with Pregnancy

    On August 9, the National Comprehensive Cancer Network (NCCN) announced the publication of a new set of guidelines for gestational trophoblastic neoplasia (GTN), also known as gestational trophoblastic disease (GTD), a group of rare cancers that can affect women during pregnancy. GTN can occur when tumors develop in the cells that would normally form the placenta during pregnancy. It affects approximately 1 out of every 1,000 pregnancies in the United States and is more common in many Asian and African countries. The NCCN Guidelines for GTN detail treatments for several variations of the disease.

    Read the full NCCN press release here, and download this new guideline here.

    Posted 8/9/2018

  • FDA Approves Mogamulizumab-kpkc for Mycosis Fungoides, Sézary Syndrome

    On August 8, the Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo, Kyowa Kirin, Inc.) for adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Approval was based on a randomized, open-label, multicenter trial in patients with active MF or SS after at least one prior systemic therapy. The trial randomized 372 patients to either mogamulizumab-kpkc or vorinostat; progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm.

    Read the full FDA press release here.

    Posted 8/8/2018

  • CMS Gives Medicare Advantage Plans Option to Utilize Step Therapy

    Starting January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) is giving Medicare Advantage (MA) Plans the option to utilize step therapy for Part B drugs. For example, in 2019, MA Plans may now require that a beneficiary who is newly diagnosed with a condition begin treatment with the plan's most preferred, most cost-effective drug therapy before progressing to a more costly drug therapy if the initial treatment is ineffective. This change will only apply to newly prescribed medications. 

    As part of the policy announced on August 7, 2018, Medicare Advantage plans that also offer a Part D benefit will be able to cross-manage across Part B and Part D. 

    Medicare Advantage plans that choose to offer this approach to enrollees in 2019, must explicitly communicate this to beneficiaries through the Annual Notice of Change and Evidence of Coverage documents. Patients that do not want to participate in a plan that elects to adopt this step therapy approach will have the option to select a different plan.

    The ACCC policy team is currently analyzing this policy change and will provide an update to members.

    Read CMS memo to Medicare Advantage plans.

    Read CMS fact sheet on Medicare Advantage Plans and step therapy for Part B drugs.

    Posted 8/7/2018

  • FDA Warns Against Long-Term Azithromycin Use for Lung Condition in Cancer Patients

    On August 3, the Food and Drug Administration issued a warning against the long-term use of the antibiotic azithromycin (Zithromax, Pfizer Inc.) to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. The FDA is reviewing additional data and will communicate its conclusions and recommendations when its review is complete.

    The serious lung condition for which long-term azithromycin was being studied, called bronchiolitis obliterans syndrome, is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Cancer patients who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome.

    Azithromycin is not approved for preventing bronchiolitis obliterans syndrome; there are no known effective antibiotic treatments for prophylaxis of bronchiolitis obliterans syndrome. Health care professionals should not prescribe long-term azithromycin for prophylaxis of bronchiolitis obliterans syndrome to patients who undergo donor stem cell transplants because of the increased potential for cancer relapse and death.

    Read the full FDA warning here.

    Posted 8/3/2018

  • CMS to Hold 8/22 Listening Session on Understanding CY 2019 PFS Proposed Rule

    On August 22, join the Centers for Medicare & Medicaid Services (CMS) for a listening session on the CY 2019 Physician Fee Schedule (PFS) proposed rule.

    During this listening session, CMS experts will briefly cover three provisions from the proposed rule and address clarifying questions to help formulate written comments for formal submission:

    • Streamlining Evaluation and Management (E/M) payment and reducing clinician burden
    • Advancing virtual care
    • Continuing to improve the Quality Payment Program to reduce clinician burden, focus on outcomes, and promote interoperability

    Participants are encouraged to review the proposed rule prior to the call, as well as the following materials on the provisions to be covered:

    This listening session will take place from 1:30 - 3:00 PM ET.

    Click here to register for this listening session as well as other Medicare Learning Network events.

    Posted 8/2/2018

  • FDA Approves Lusutrombopag for Thromocytopenia

    On July 31, the Food and Drug Administration approved lusutrombopag (Mulpleta, Shionogi Inc.) for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 109/L.

    Read the full FDA announcement here.

    Posted 8/1/2018