On August 16, 2018, the Food and Drug Administration updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) 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.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
To sign up for advocacy alerts, log in to ASCO.org with your ASCO member or guest account, and visit the subscription center available under your account profile.
Cory Wiegert has been named Chief Executive Officer of CancerLinQ LLC, a wholly owned non-profit subsidiary of ASCO, and as an Executive Vice President for ASCO
ASCO and Friends of Cancer Research have submitted to the Food and Drug Administration recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
On Aug. 8, 2018, the Food and Drug Administration 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.
ASCO strongly opposes the Centers for Medicare & Medicaid Services (CMS) decision to allow Medicare Advantage plans to employ step therapy across physician-administered and self-administered drugs under Medicare Part B and Part D.
In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis discusses the recently released Medicare Physician Fee Schedule (MPFS) proposed rule. The MPFS is a complete listing of all fees Medicare uses to reimburse doctors and other providers and suppliers under a fee-for-service payment system.
Representatives from ASCO and other medical specialty groups recently met with officials from the U.S. Department of Health and Human Services (HHS) to discuss the 2019 Medicare Physician Fee Schedule (MPFS). The meeting provided Administration officials with an opportunity to explain provisions in the 2019 MPFS proposed rule and for stakeholders to ask questions and express their concerns with the proposal.
The agenda for the 2018 ASCO Oncology Practice Conference has been finalized. The conference will take place September 27, 2018, at the JW Marriott Phoenix Desert Ridge in Phoenix, Ariz., and registration is open. The hotel reservation and early registration deadline is August 22 at 11:59 p.m. (EDT).
Merit-based Incentive Payment System (MIPS) final score and performance feedback are now available for review on the Quality Payment Program website for physicians that participated in MIPS in 2017.
ASCO has submitted joint responses with the American Association for Cancer Research (AACR) to three Advance Notices of Proposed Rulemaking (ANPRM) issued by the Food and Drug Administration (FDA) related to tobacco regulation. The comment letters responded to setting a nicotine level standard, using flavors in tobacco products, and regulating cigars.
ASCO submitted a statement to the U.S. House of Representatives Energy and Commerce Committee in conjunction with a subcommittee hearing on implementation of the Merit-Based Incentive Payment System (MIPS) under the Medicare Access and CHIP Reauthorization Act (MACRA).
ASCO has been notified that Takeda Oncology was recently advised by the U.S. Food and Drug Administration that the Risk Evaluation and Mitigation Strategy communication plan for ICLUSIG® (ponatinib) is no longer required.
On July 31, 2018, the Food and Drug Administration approved lusutrombopag (Mulpleta®, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
On July 30, 2018, the Food and Drug Administration approved iobenguane I 131 (AZEDRA®, Progenics Pharmaceuticals, Inc.) for adult and pediatric patients (12 years and older) with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.
On July 25, the U.S. House Energy and Commerce Committee held a hearing during which Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, Director of the National Cancer Institute (NCI) Norman Sharpless, MD, and Director of National Institutes of Health Francis Collins, MD, PhD, provided updates on how their respective agencies have been implementing the 21st Century Cures legislation.