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.
Allogeneic CAR T-Cell Therapy Shows Promising Efficacy Without GVHD
January 29th 2016Treatment with allogeneic anti–CD19 chimeric antigen receptor–modified T cell therapy induced complete remissions in 30% of patients with advanced progressive B-cell malignancies without causing graft-versus-host disease.
HER2 Subtype Offers Clues for Individualizing Breast Cancer Care
January 29th 2016One-third of patients previously identified as having HER2-positive breast cancer were found to also have a luminal subtype that was resistant to chemotherapy and trastuzumab but still sensitive to the triplet neoadjuvant regimen of pertuzumab, trastuzumab, and chemotherapy.
FDA Grants Venetoclax Breakthrough Designation in AML
January 28th 2016Venetoclax has received an FDA breakthrough therapy designation for use in combination with hypomethylating agents in treatment-naïve patients with acute myeloid leukemia who are not eligible for standard high-dose induction treatment.
FDA Grants Olaparib Breakthrough Designation in mCRPC
January 28th 2016Olaparib (Lynparza) has received an FDA breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer in those who have received a prior taxane-based chemotherapy and at least either hormonal agent enzalutamide (Xtandi) or abiraterone acetate (Zytiga).
Patients With Low-Risk Thyroid Microcarcinoma Benefit More With Active Surveillance
January 27th 2016Results of a recent study show that patients with low-risk thyroid-related microcarcinoma who choose to undergo immediate surgery are at higher risk for adverse events and unnecessary risk compared with those who decide on active surveillance.
Vaccine Strategy for Biomarker in NSCLC Reaches Phase III Study
January 27th 2016An emerging vaccine strategy, of TG4010 immunotherapy and first-line chemotherapy, that could target a potential new biomarker in patients with advanced non-small cell lung cancer (NSCLC) has successfully reached a phase III clinical trial, researchers noted.
FDA Approves Carfilzomib Combo for Relapsed Multiple Myeloma
January 21st 2016The FDA has approved carfilzomib (Kyprolis) in combination with dexamethasone or with lenalidomide plus dexamethasone for patients with relapsed/refractory multiple myeloma following prior treatment with 1 to 3 lines of therapy
Lenvatinib/Everolimus Combo Submitted for Approval in Advanced RCC
January 15th 2016Regulatory filings have been submitted in the United States and Europe for the combination of lenvatinib and everolimus as a treatment for patients with metastatic renal cell carcinoma following a VEGF-targeted therapy.