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Oncology Newsfeed

  • FDA Approves Padcev (enfortumab vedotin-ejfv) for Advanced Urothelial Cancer

    On Dec. 18, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.

    Padcev is indicated for the treatment of locally advanced or metastatic urothelial cancer in adults who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. Platinum-containing chemotherapy, PD-1 and PD-L1 inhibitors are standard treatments for patients with bladder cancer, the sixth most common cancer in the U.S. Urothelial cancer, which accounts for more than 90% of bladder cancers, begins in cells that line the bladder and nearby organs. Padcev is a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.

    Read FDA announcement.

    Posted 12/19/2019 


  • Trump Administration Issues Proposed Rule on Importation of Prescription Drugs

    On Dec. 18, 2019, President Trump, along with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow states to import certain prescription drugs from Canada. In addition, the administration announced a new draft guidance for industry that allows drug manufacturers to important their own prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

    The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)

    Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.

    Read the HHS press release.
    Read Importation of Prescription Drugs Proposed Rule.
    Read new draft guidance for industry.



  • FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

    On Dec. 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).

    FDA previously approved enzalutamide for patients with castration-resistant prostate cancer.

    Read the FDA announcement    .

    Posted 12/17/2019



  • CMS Extends Open Enrollment Deadline to Dec. 18

    On Dec. 16, 2019, a spokesperson for the Centers for Medicare & Medicaid Services (CMS) issued the following statement:

    "In an abundance of caution, to accommodate consumers who attempted to enroll in coverage during the final hours of Open Enrollment but who may have experienced issues, starting at 3:00 PM EST today, December 16 we are extending the deadline to sign up for January 1 coverage until 3:00 AM EST December 18."

    The website and the call center were open for business on Sunday, December 15, CMS says. However, due to the high volume of consumers (more than half a million) calling to enroll in health insurance on the exchange, some consumers were asked to leave their name at the call center. The agency states: "Those consumers who have already left their contact information at the call center do not need to come back and apply during this extension because a call center representative will follow up with them later this week.”

    Read CMS statement on Health Insurance Exchange Open Enrollment Extension.

    Posted 12/16/2019


  • Senate Confirms Dr. Stephen Hahn as U.S. FDA Commissioner

    On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).

    Posted 12/12/2019  



  • Inside Health Policy Reports: CMS to Repay Hospitals for 2019 Site-Neutral Pay Cut

    On Dec. 11, 2019, Inside Health Policy reported that the Centers for Medicare & Medicaid Services (CMS) "plans to repay hospitals that sued over 2019 pay cuts from the agency’s so-called site-neutral policy. The agency has also updated the 2019 pay rates for clinic visits at certain off-campus hospital facilities to remove the cut in light of a federal court decision that said the agency didn’t have the authority to implement it."

    In September 2019, a Federal Washington, D.C., District Court judge found that CMS exceeded its authority in introducing these cuts in the 2019 Hospital Outpatient Prospective Payment System (HOPPS) rule. Several stakeholder organizations filed suit against CMS in response to the final 2019 (HOPPS) rule's provision that established a new reimbursement rate for off-campus hospital outpatient department clinic visits that aligned the payment rate with that under Medicare's Physician Fee Schedule. The 2019 HOPPS rule extended these payment cuts to providers that were specifically exempted from these site-neutrality reimbursement reductions by the Bipartisan Budget Act of 2015.

    Inside Health Policy reports that the "American Hospital Association, Association of American Medical Colleges and others that sued CMS over the cuts say in a Dec. 9 court notice that some hospitals 'recently received payments for claims processed over the past few weeks at the pre-2019 OPPS Rule payment rates for challenged services.' "

    Inside Health Policy further reports that: "the [court] notice says that hospitals haven’t been reimbursed for claims from previous months in 2019 and the government has not 'receded from its stated intention to continue to implement in 2020 the same plan this court already vacated.' "

    CMS told Inside Health Policy that it began paying hospitals the higher reimbursement rate as of Nov. 4, and that Medicare Administrative Contractors will reprocess claims previously subject to the cut during the first few months of 2019.

    ACCC's policy team will provide more information when it becomes available.

    Posted 12/12/2019






  • ASTRO Issues New Clinical Guideline for Radiation Therapy for BCC and cSCC

    On Dec. 10, 2019, the American Society for Radiation Oncology (ASTRO) issued a new clinical guideline on the use of radiation therapy to treat patients diagnosed with basal cell and cutaneous squamous cell carcinomas (BCC, cSCC). The guideline suggests dosing and fractionation for these treatments.

    An executive summary and full-text version of ASTRO's first guideline for skin cancer are published online in Practical Radiation Oncology.

    Read ASTRO press release.

    Posted 12/10/2019


  • NCCN Updates Genetic Testing Guidelines for Assessing Breast, Ovarian, and Pancreatic Cancer Risk

    On Dec. 4, 2019, the National Comprehensive Cancer Network (NCCN) announced publication of updated genetic risk assessment recommendations for breast, ovarian and pancreatic cancers. Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic Version 1.2020 include new and expanded sections on risk assessment and management related to these cancer types, but retains a conservative approach toward testing practices where evidence is still lacking. 

    Read NCCN press release.

    Posted 12/6/2019


  • FDA Approves Atezolizumab + Chemotherapy for Metastatic Non-Squamous NSCLC

    On Dec. 3, 2019, the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

    Read the corporate announcement.

    Read FDA announcement.

    Posted 12/04/2019; updated 12/06/2019


  • ACCC Dec. 5 Webinar on CY2020 Medicare Final Payment Rules

    On Thursday, Dec. 5 the Association of Community Cancer Centers (ACCC) will host a members-only webinar on the Centers for Medicare & Medicaid Services (CMS) CY2020 Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) final rules.

    ACCC's summaries of the CY 2020 OPPS final rule  MPFS final rule are available here [login required].

    Webinar 
    CMS CY2020 OPPS & PFS Final Rules: What You Need to Know
    Thursday, December 5, 2019
    2:00 – 3:00 PM EST

    REGISTER HERE. [Login required]

    Posted 11/27/2019