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).
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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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.
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.
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 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.
On April 30, 2018, the Food and Drug Administration granted regular approval to dabrafenib (TAFINLAR®, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST®, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
On April 18, 2018, the Food and Drug Administration approved osimertinib (Tagrisso®, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
On April 17, 2018, the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE™, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
National Prescription Drug Take Back Day—April 28, 2018— is a nationwide event to educate the public on the safe storage and disposal of drugs and to help patients safely, conveniently, and responsibly dispose of unused or expired opioids and other prescription medications throughout the year. On Take Back Day, patients can visit collection sites near them to turn in medications.
Last month, the Food and Drug Administration (FDA) held a listening session where stakeholders, including ASCO’s Chief Medical Officer, Richard L. Schilsky, MD, FACP, FSCT, FASCO, offered brief comments on role of the Oncology Center of Excellence (OCE).
On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo® and Yervoy®, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.