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Oncology Newsfeed

  • FDA Approves First Biosimilar to Rituxan

    On November 28, the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

    Read the full FDA press release here.

    Posted 11/28/2018


  • FDA Approves Gilteritinib for Acute Myeloid Leukemia

    On November 28, the Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma US Inc.) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

    The FDA also approved an expanded indication for a companion diagnostic, to include use with gilteritinib. The LeukoStrat CDx FLT3 Mutation Assay, (Invivoscribe Technologies, Inc.) is used to detect the FLT3 mutation in patients with AML.

    Read the full FDA press release here.

    Posted 11/28/2018



  • FDA Approves Larotrectinib for Solid Tumors with NTRK Gene Fusion

    On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

    Read the full FDA press release here.

    Posted 11/27/2018


  • CMS Releases Medicare Part C and Part D Proposed Rule

    On November 26, the Centers for Medicare & Medicaid Services (CMS) announced proposed policies that continue to tackle drug pricing reform. Top-line takeaways from today’s proposals include:

    • Proposed reform to Medicare Part D’s “protected” therapeutic classes.
    • A new requirement in Medicare Part D to allow for increased transparency between patient and provider with provision of out-of-pocket cost obligations for prescription drugs whenever a prescription is written.
    • A continued push to allow for and implement “step therapy” in Medicare Advantage plans for Part B drugs. The proposed rule also states the potential to infuse prior authorizations within this pool as well.
    • Proposed implementation of a “statutory requirement” that would prohibit pharmacy gag clauses in Part D.

    Read the CMS fact sheet on the proposed rule here.
    Read the full proposed rule here.

    The ACCC policy team is continuing to analyze this proposal. Stay tuned for more updates.

    Posted 11/26/2018


  • ACCC Signs Letter of Support for CLINICAL TREATMENT Act

    On November 26, the Association of Community Cancer Centers (ACCC) joined dozens of cancer care organizations and associations in signing a letter of support for H.R. 6836, the CLINICAL TREATMENT Act. This legislation would ensure that states cover routine care costs of participation in approved clinical trials for Medicaid enrollees with life-threatening conditions. Medicaid is currently the only major payer that is not required by federal law to cover these costs.

    Read the full letter of support for H.R. 6836 here.

    Posted 11/26/2018


  • FDA Approves Venetoclax for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/18



  • FDA Approves Glasdegib for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/2018


  • ACS Releases Report on Current State of Cancer Screening

    On November 19, the American Cancer Society (ACS) published a report in CA: A Cancer Journal for Clinicians discussing the status of cancer screening and proposing key areas where further attention is needed. ACS highlighted five key focus areas to help cancer screening realize its full potential:
    • Improving the implementation of existing screening modalities
    • Improving the quality and performance of currently available screening tests
    • Developing entirely new screening strategies to screen for cancers currently amenable to screening
    • Developing increasingly refined, risk-based screening strategies
    • Developing effective ways to screen for cancers for which screening tests do not exist.
    Read the full report here.

    Read the ACS press release on the report here.

    Posted 11/19/2018


  • "Feel More Like You" Program to Help Cancer Patients with Physical Changes

    On November 19, Walgreens announced the launch of its "Feel More Like You" program designed to assist people living with cancer manage the physical changes associated with treatment. Formed in collaboration with Look Good, Feel Better and Cancer Support Community, the program will feature trained beauty consultants and pharmacists working together to provide personalized support to individuals with cancers at more than 400 stores across the country.

    Read the full Walgreens press release here.

    Posted 11/19/18


  • FDA Approves Brentuximab Vedotin for Peripheral T-Cell Lymphoma

    On November 16, the U.S. Food and Drug Administration expanded the approved use of brentuximab vedotin (Adcetris, Seattle Genetics) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnoses PTCL, and the agency used a new review program to complete the approval more quickly.

    Read the full FDA press release here    .

    Posted 11/16/2018