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.
ODAC Unanimously Recommends Approval of Tisagenlecleucel for Pediatric ALL
July 12th 2017Oncologic Drugs Advisory Committee voted 10-0 today to recommend approval of a biologics license application for tisagenlecleucel (CTL019) for the treatment of patients aged 25 or younger with relapsed/refractory B-cell acute lymphoblastic leukemia.
Published Ipilimumab/Nivolumab Data Highlight Activity in Metastatic RCC
July 12th 2017Patients with metastatic renal cell carcinoma had an objective response rate of 40% and a 2-year overall survival rate of nearly 70% with the immune checkpoint combination of ipilimumab (Yervoy) and nivolumab (Opdivo), in phase I results from CheckMate-016.
ODAC Recommends Approval of Gemtuzumab Ozogamicin for Newly-Diagnosed AML
July 11th 2017The FDA’s Oncologic Drugs Advisory Committee voted 6-1 in favor of approving gemtuzumab ozogamicin (Mylotarg) in combination with daunorubicin and cytarabine for the treatment of patients with newly-diagnosed CD33-positive acute myeloid leukemia.
Analysis Shows Response to Ibrutinib in CLL Patients With 11q Deletion
July 11th 2017Thomas Kipps, MD, PhD, discusses the details of the integrated analysis from the iwCLL meeting, his ongoing research with ROR1 as a target in chronic lymphocytic leukemia, and pivotal combination studies being conducted with ibrutinib.
Lapatinib/Trastuzumab/AI Triplet Nearly Doubles PFS in HER2+/HR+ Metastatic Breast Cancer
July 7th 2017The triplet combination of HER2-targeted therapy and an aromatase inhibitor improved progression-free survival by more than 5 months compared with the combination of trastuzumab (Herceptin) and an aromatase inhibitor in patients with HER2+/HR+ breast cancer.
Expert Stresses Need for Lung Cancer Screening to Be More Mainstream
July 7th 2017Pierre Massion, MD, on the necessity of having more people undergo lung cancer screening, ongoing clinical trials emphasizing the importance of early detection, and how to determine who is at highest risk for lung cancer.
Positive Results from First Randomized Study Assessing T-VEC/Ipilimumab Combo in Advanced Melanoma
July 7th 2017The addition of T-VEC (T-VEC; Imlygic), a herpes simplex virus 1-based oncolytic virus, to CTLA-4 inhibitor ipilimumab (Yervoy) improves the objective response rate in patients with unresected stage IIIb to IV melanoma.
FDA Places Clinical Hold on 3 Pembrolizumab Myeloma Trials
July 6th 2017The FDA has placed a clinical hold on the phase III KEYNOTE-183 and KEYNOTE-185 pembrolizumab (Keytruda) trials and ordered the discontinuation of the lenalidomide/dexamethasone/pembrolizumab arm of the KEYNOTE-023 trial in patients with multiple myeloma.
Expert Discusses Dramatic Impact of Immunotherapy on NSCLC Paradigm
July 6th 2017Melissa Johnson, MD, discusses the impact of immunotherapy for patients with non-small cell lung cancer—those with both high and low levels of PD-L1 expression—and how the treatment and the role of PD-L1 will continue to progress in the coming years.