The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Daratumumab Plus Lenalidomide/Dexamethasone Improves PFS in Frontline Myeloma Trial
October 30th 2018Adding daratumumab to lenalidomide and dexamethasone reduced the risk of disease progression or death by 45% compared with lenalidomide/dexamethasone alone in newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant.
FDA Grants Priority Review to Ruxolitinib for GVHD
October 26th 2018The FDA has granted a priority review designation to a supplemental new drug application for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.
FDA Grants Priority Review to TAS-102 for Gastric/GEJ Cancer
October 26th 2018The FDA has granted a priority review to a supplemental new drug application for TAS-102 for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.
Pembrolizumab Active in BCG-Unresponsive NMIBC
October 24th 2018An interim analysis of an ongoing single-arm open-label phase II study showed encouraging antitumor activity with pembrolizumab (Keytruda) in patients with high-risk nonmuscle invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin.
City of Hope President Elected to Distinguished National Academy of Medicine
October 23rd 2018Michael A. Caligiuri, MD, president of City of Hope National Medical Center, and Deana and Steve Campbell Physician-in-Chief Distinguished Chair, has been elected to the National Academy of Medicine, one of the highest honors in the fields of health and medicine.