On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI®, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.
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 November 21, 2018, the Food and Drug Administration granted accelerated approval to venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
On November 21, 2018, the Food and Drug Administration approved glasdegib (DAURISMO™, Pfizer Labs) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.
On November 20, 2018, the Food and Drug Administration approved emapalumab (GAMIFANT, Novimmune SA), a monoclonal antibody that binds and neutralizes interferon gamma, for adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
The ASCO Research Community Forum (RCF) will be hosting a free webinar on Wednesday, December 12, 2018 from 12-1 p.m. ET to share highlights from this year’s RCF Annual Meeting workshop. Participants can gain valuable, actionable resources to implement in their own research programs.
On November 14, the Food and Drug Administration (FDA) announced new action to ban flavored e-cigarettes (e-cigs) at convenience stores. The ban follows the agency’s September announcement of its new Youth Tobacco Prevention Plan to address the alarming rates at which children and young adults are using e-cigs.
On December 5 from 4:00-5:00 PM ET, ASCO will host the latest installment in its webinar series on the 2019 Medicare Physician Fee Schedule (MPFS). This webinar, 2019 Medicare Reimbursement – Final Rules Update, comes as the Centers for Medicare & Medicaid Services (CMS) recently released its final rule outlining reimbursement changes to the MPFS, Quality Payment Program (QPP) and Hospital Outpatient Prospective Payment System (HOPPS) for 2019.
Effective January 1, 2019, Medicare is instituting new opioid prescribing policies that will impact Medicare Part D beneficiaries with a prescription drug benefit and their prescribers. Major changes are summarized below; for additional information please see the full Medicare Learning Network article.
On November 16, 2018, the Food and Drug Administration approved brentuximab vedotin (ADCETRIS®, Seattle Genetics Inc.) in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL including sALCL.
The MNGHA-Cancer Center in Saudi Arabia, the first in the Middle East, has joined seven other practices in Brazil, Greece, Romania, and Spain in achieving ASCO’s Quality Oncology Practice Initiative (QOPI®) Certification.
In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis reviews the results of ASCO’s 2018 National Cancer Opinion survey, which examined the views held by Americans on a wide range of cancer-related issues.
Update: ASCO’s resolutions on step therapy, Medicare Part B drugs, a Competitive Acquisition Program (CAP), and clinical trial access were adopted or reaffirmed by the American Medical Association (AMA) House of Delegates, as well as an ASCO-backed resolution on Qualified Clinical Data Registries (QCDRs).
On November 9, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
On November 8, 2018, ASCO and the National Comprehensive Cancer Network® (NCCN®) held a meeting with key stakeholders with the goal of developing consistency and harmony among clinical practice guidelines for pain control in individuals with cancer-related pain, as well as to address the critical pain management needs of patients with sickle cell disease.
On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA®, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.