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.
Expert Says Nivolumab Poised to Change Standard of Care in SCCHN
August 23rd 2016Robert L. Ferris, MD, PhD, discusses the findings of the CheckMate-141 study, potential biomarkers for nivolumab (Opdivo), and questions that remain regarding the use of the immunotherapy in squamous cell carcinoma of the head and neck.
EMA Initiates Official Regulatory Review of Neratinib in HER2+ Breast Cancer
August 23rd 2016The European Medicines Agency has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab.
Pembrolizumab to Have Critical Role in Head and Neck Cancer Treatment
August 21st 2016Joshua M. Bauml, MD, discusses the impact of pembrolizumab's (Keytruda's) success in recurrent or metastatic head and neck squamous cell carcinoma, the results of the KEYNOTE-055 study, and what he sees on the horizon for the PD-1 inhibitor in this field.
FDA Approval Sought for Daratumumab Combos in Multiple Myeloma
August 18th 2016A supplemental biologics license application has been submitted to the FDA for the use of daratumumab (Darzalex) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone as a treatment for patients with multiple myeloma following at least 1 prior therapy.
Venetoclax Shows Single-Agent Activity in AML
August 16th 2016Treatment with single-agent BCL-2 inhibitor venetoclax demonstrated an overall response rate of 19% with a tolerable safety profile in patients who were unfit for intensive chemotherapy for those with relapsed/refractory acute myeloid leukemia.
Combo Trials Aim to Clarify Optimal Radium-223 Use in mCRPC
August 16th 2016Russell Szmulewitz, MD, discusses the unknown optimal use of radium-223 dichloride (Xofigo), the appropriate time to administer it, and the associated challenges with the agent for the treatment of patients with metastatic castration-resistant prostate cancer.
"Stemness" Inhibitor Demonstrates Activity in Patients With Advanced Ovarian Cancer
August 12th 2016Results of an early phase trial show that, for heavily pretreated patients with platinum-resistant ovarian cancer, a first-in-class cancer "stemness" inhibitor that targets the STAT3 pathway was found to demonstrate antitumor activity—and was also found to be well tolerated when combined with paclitaxel.
Immunotherapy Transforms Melanoma Care, But Challenges Remain
August 12th 2016Norman E. Sharpless, MD, discusses the impact of the CheckMate-069 trial, the toxicities that are associated with nivolumab (Opdivo)/ipilimumab (Yervoy), and what the future holds for immunotherapy combinations in the field of melanoma.
Expert Explores Next Steps With "Game Changer" Atezolizumab in Bladder Cancer
August 11th 2016Gary D. Steinberg, MD, discusses the impact of atezolizumab (Tecentriq) on the treatment landscape of bladder cancer, the resistance to finding effective therapies for the disease, and what potential role immunotherapy may have in the field going forward.
Early Abemaciclib Data Not Sufficient to Halt Phase III Breast Cancer Trial
August 10th 2016The phase III MONARCH 2 study assessing abemaciclib in HR-positive, HER2-negative advanced breast cancer will continue after the CDK4/6 inhibitor did not meet the efficacy criteria at an interim analysis required to stop the trial early.
Expert Explains Significance of Early Tumor Shrinkage in Metastatic Colorectal Cancer
August 10th 2016Volker Heinemann, MD, PhD, discusses the connection between early tumor shrinkage and overall survival, depth of response, and what it could mean for the future of metastatic colorectal cancer treatment.
Rucaparib's Efficacy in Ovarian Cancer Determined With Novel Biomarker
August 9th 2016While BRCA status continues to be a predictive indicator of response to rucaparib for patients with ovarian cancer, loss of genomic heterozygosity was shown to also be an effective biomarker for predicting outcomes.