On February 16, 2018, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca Inc.) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
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 February 14, 2018, the Food and Drug Administration approved apalutamide (Erleada™, Janssen Biotech, Inc.) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).
On February 7, 2018, the Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga®, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).
On January 26, 2018, the Food and Drug Administration approved lutetium Lu 177 dotatate (LUTATHERA®, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
The U.S. Department of Health and Human Services (HHS) announced that implementation of the updated Common Rule will be delayed until July 19, 2018 instead of taking effect on January 19, 2018.
The Oncology Center of Excellence of the Food and Drug Administration is informing health care providers about new safety information for Varubi® (rolapitant) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults.
On January 12, 2018, the Food and Drug Administration granted regular approval to olaparib tablets (Lynparza® , AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.
On January 12, 2018, the Food and Drug Administration granted approval to afatinib (Gilotrif®, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
ASCO submitted comments to the U.S. Food and Drug Administration (FDA) to help guide its newly established Opioid Policy Steering Committee (OPSC). In the comments, ASCO responded to several FDA-posed questions to inform OPSC’s work of effectively addressing the nation-wide opioid crisis.