On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet®, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.
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.
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On May 18, 2018, the U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
On May 17, the Senate Appropriations Committee held a hearing to discuss the budget request for the National Institutes of Health (NIH) for Fiscal Year (FY) 2019. NIH Director Francis Collins, MD, PhD, and National Cancer Institute (NCI) Director Ned Sharpless, MD, both gave testimony at the hearing, where Dr. Sharpless underscored the need for adequate funding to strengthen the cancer research infrastructure.
The agenda has been set for the June 22 ASCO/Food and Drug Administration (FDA) “Core Outcome Assessments in Cancer Clinical Trials” workshop.
ASCO has been notified about a recent safety update relating to the drug BLINCYTO® (blinatumomab) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program.
In the newest ASCO in Action podcast, Dr. Gary H. Lyman, MPH, FASCO, FRCP, joins ASCO CEO Dr. Clifford A. Hudis to discuss biosimilars and ASCO’s recent statement on biosimilars published in the Journal of Clinical Oncology. Dr. Lyman is chair of the ASCO Biosimilars Work Group and lead author of the ASCO statement, which aims to educate cancer care providers on the use and regulation of biosimilars.
The Food and Drug Administration (FDA) is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam because of outbreaks of the Burkholderia cepacia complex (commonly called B. cepacia) in three states. The
On May 15, 2018, the Food and Drug Administration approved Retacrit™ (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study now provides a full list of patient cohort expansions and closures on its website. Based on treatment responses in Stage I, patient cohorts are either expanded to Stage II for further study and identification of a signal or permanently closed. ASCO’s TAPUR Study offers a clinical trial opportunity for patients with advanced cancer who have not responded or are no longer responding to standard treatment and who have genomic alterations in their tumors that can be targeted with a TAPUR Study drug.
On May 8, the White House submitted a rescission package to Congress, which proposes $15 billion in cuts to 38 government programs and agencies, including to the Center for Medicare and Medicaid Innovation.
This ASCO in Action Brief is designed to help ASCO members gain a clearer understanding of the impact of state and federal right-to-try (RTT) legislation in the United States on oncology patients and practices.
On May 6, the National Institutes of Health (NIH) began national enrollment for its All of Us Research Program. All of Us is a major component of the Precision Medicine Initiative, which aims to gather data from more than one million people living in the United States to speed up health research breakthroughs and create individualized prevention, treatment, and care for all patients.
On May 4, 2018, the Food and Drug Administration approved dabrafenib (TAFINLAR®, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST®, Novartis Pharmaceuticals Corp.) in combination for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
On May 1, 2018, the Food and Drug Administration approved tisagenlecleucel (KYMRIAH™, Novartis Pharmaceuticals Corp.) a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
ASCO’s Policy Issue Briefs provide succinct overviews and relevant data on major policy issues impacting patients with cancer and the physicians who care for them. These briefs are designed to be especially helpful for journalists, offering background information on key issues across health policy today.