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Oncology Newsfeed

  • Three Foundations Commit 30 Million Dollars to Nonprofit Generic Drug Company

    On September 6, the Laura and John Arnold Foundation, Peterson Center on Healthcare, and Gary and Mary West Foundation announced that they have committed $30 million to help establish Civica Rx, a new nonprofit generic drug company. The foundations join hospital groups representing more than 450 hospitals in the creation of the company.

    Civica Rx has identified 14 hospital-administered generic drugs as its initial focus, seeking to stabilize the supply of essential medications, many of which have fallen into chronic shortage situations. The company expects its first products to be released in early 2019.

    Read the full press release here.

    Posted 9/6/2018


  • CMS Issues Changes to Part D Formulary Options in 2020

    On Wednesday, August 29, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a memo to Medicare Part D plans that will allow these plans to implement “indication-based formulary design” starting in 2020.

    Currently, if a Part D plan includes a specific drug on its formulary, the plan must cover that drug for every FDA-approved indication, or patient condition, even if the plan would otherwise instead cover a different drug for a particular indication.

    The CMS memo states that if a Part D plan limits formulary coverage of a drug to certain indications, the plan must ensure that there are other therapeutically similar drugs on formulary for the drug’s non-covered indications. 

    The ACCC policy team is currently reviewing this policy change.

    Read the CMS memo to Part D plans.
    Read the agency's fact sheet.

    Posted 8/29/2018



  • FDA Approves Ibrutinib Plus Rituximab for Rare Blood Cancer

    On August 27, AbbVie announced that the FDA has approved ibrutinib (Imbruvica) (Pharmacyclics, LLC) plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). This approval represents the first and only chemotherapy-free combination treatment specifically indicated for the disease.

    Read the full AbbVie corporate press release here.

    Posted 8/27/2018


  • FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC

    On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

    Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.

    Read the full FDA announcement here.

    Posted 8/20/2018



  • 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