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Oncology Newsfeed

  • FDA Approves Avelumab Plus Axitinib for Advanced RCC

    On May 14, Pfizer Inc. announced that the FDA has approved avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). A Phase III study showed that the combination significantly lowered risk of disease progression or death by 31 percent and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib.

    Read the Pfizer press release.

    Posted 5/15/2019



  • FDA Issues Final Guidance to Manufacturers on Biosimilars' Pathway to Interchangeability

    On May 10, the U.S. Food and Drug Administration (FDA) released its final guidance to drug manufacturers with direction on what studies need to show the agency in how a biosimilar is interchangeable with a biologic. The healthcare community, and specifically, the oncology community, has called upon the FDA and Congress to increase the availability and competition of biosimilars.  

    Read statement from acting FDA Commissioner Ned Sharpless, MD.

    Posted 5/13/2019



  • FDA Approves Ramucirumab for HCC

    On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.

    Read the FDA press release here.

    Posted 5/10/2019


  • FDA Approves Ado-Trastuzumab Emtansine for HER2+ Breast Cancer

    On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1) (Kadcyla, Genentech Inc.) for use as an adjuvant treatment option for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (Herceptin) and chemotherapy.

    Read the TargetedOnc article here.

    Posted 5/3/2019


  • FDA Approves Ivosidenib for AML

    On May 2, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

    Read the FDA press release here.

    Posted 5/3/2019


  • AUA Releases New Guidance for Testicular Cancer, Radiotherapy after Prostatectomy

    On May 2, the American Urological Association (AUA) released a new clinical guideline for the diagnosis and treatment of early-stage testicular cancer, the most common cancer among men aged 20 to 40. The new clinical guideline makes 45 recommendations, including recommendations for scrotal ultrasound, obtaining serum tumor markers, and sperm banking prior to orchiectomy.

    Read the AUA press release.
    Read Diagnosis and Treatment of Early State Testicular Cancer: AUA Guideline (2019).

    On April 30, AUA and the American Society for Radiation Oncology (ASTRO) announced updates to their joint clinical guideline on adjuvant and salvage radiotherapy after prostatectomy in patients with and without evidence of prostate cancer recurrence to include new published research related to adjuvant radiotherapy.

    Read the AUA press release.
    Read Adjuvant and Radiotherapy after Prostatectomy: ASTRO/AUA Guideline.

    Posted 5/2/2019


  • ACS: More than Half of Americans Report Medical Financial Hardship

    A new study by researchers from the American Cancer Society (ACS) finds that approximately 137 million adults in America (56 percent) reported having medical financial hardship in the past year. Highlights of the report include:

    • Adults aged 18 to 64 reported higher material (i.e. trouble paying medical bills), psychological (i.e. concern about medical bills), and behavioral (delaying or forgoing care because of cost) medical financial hardship than those aged 65 and older.
    • Among adults aged 18 to 64, those with less education and more health conditions reported greater intensity of hardship.
    • Women were more likely to report multiple domains of hardship than men.
    • Uninsured adults were more likely to report multiple domains of hardship than those with public or private insurance.
    2017 ACCC Annual Achievement Award winner Barbara McAneny, MD, president of the American Medical Association, says of the study in the Los Angeles Times, "People are trying hard to do the right thing, but care is being prices out of their reach."

    Read the ACS press press release.
    Read the Los Angeles Times article.
    Read "Prevalence and Correlates of Medical Financial Hardship in the USA" in the Journal of General Internal Medicine.

    Posted 5/2/2019


  • AHA Releases Scientific Statement on Cardio-Oncology Rehabilitation

    The American Heart Association (AHA) has published a scientific statement in the journal Circulation outlining the need to develop and test cardio-oncology rehabilitation programs for patients at high risk for cardiac dysfunction during and after cancer treatment. The statement outlines the process for identifying at-risk patients and the infrastructure needed to address the unique exposures and complications related to cardiac rehabilitation.

    Read the AHA journal article here.

    Posted 4/25/2019


  • CMS Releases IPPS Proposed Rule

    On April 23, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for fiscal year (FY) 2020.

    In the IPPS proposed rule, the agency proposes to:

    • increase the wage index of low wage index hospitals
    • support broad access to "transformative technologies" by proposing several payment policy changes, including increasing the new technology add-on payment
    • modernize payment policies for medical devices that meet FDA Breakthrough Devices designation
    The agency fact sheet specifically addresses CAR-T therapy in the context of applications for new technology add-on payments for FY 2020. In the proposed rule, CMS presents 17 new applications for new technology add-on payment for FY 2020, and proposes to continue the new technology add-on payments for 10 of the 13 technologies currently receiving the add-on payment (3 technologies will no longer be in their newness period in FY 2020). Two of the technologies CMS is proposing to continue payments for are types of chimeric antigen receptor (CAR) T‑cell therapy.

    The ACCC policy team is analyzing the proposed rule and will provide a more in-depth analysis to members shortly.

    Read the agency fact sheet.
    Access the proposed rule.

    Posted 4/23/2019



  • FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma

    On April 19, the FDA approved pembrolizumab (Keytruda, Merck & Co. Inc.) plus axitinib (Inlyta, Pfizer Inc.) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

    Read the full FDA press release here.

    Posted 4/22/2019