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.
Durvalumab Granted Breakthrough Status for Bladder Cancer
February 17th 2016The FDA has granted a breakthrough therapy designation to durvalumab as a treatment for patients with PD-L1–positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen.
Expert Discusses Exciting Potential for Atezolizumab in Bladder Cancer
February 15th 2016Arjun V. Balar, MD, discusses the phase II data demonstrating the efficacy of atezolizumab as a single agent, its potential as part of combination regimens, and planned clinical trials looking at immunotherapy in patients with metastatic bladder cancer.
Patient Populations Provide Sequencing Clues in Chemorefractory CRC
February 11th 2016Treating patients with chemorefractory advanced colorectal cancer has undergone a significant transformation in recent years. Now, with two agents approved, the optimal sequence for therapies regorafenib and TAS-102 becomes the next relevant question.
FDA Grants T-Cell Therapy Breakthrough Designation in Sarcoma
February 9th 2016An affinity enhanced T-cell therapy has received an FDA breakthrough therapy designation for the treatment of patients with inoperable or metastatic pretreated synovial sarcoma who harbor HLA-A*201, HLA-A*205, or HLA-A*206 alleles and whose tumors express the NY-ESO-1 tumor antigen.
Melanoma Brings Immunotherapy to the Forefront, But Challenges Remain
February 9th 2016Jeffrey S. Weber, MD, PhD, discusses the role that melanoma specialists can play in educating other oncologists, immunotherapy use for BRAF-mutated patients with melanoma, and how the use of chemotherapy may evolve as immunotherapies take the forefront.
ASCO Guideline Clarifies Biomarker Assay Use in Adjuvant Breast Cancer Care
February 8th 2016ASCO released new evidence-based recommendations to ensure appropriate use of biomarker assay results in guiding decisions on adjuvant therapy for women with early-stage invasive breast cancer and known estrogen receptor, progesterone receptor, and HER2 status.
Blinatumomab Improves Survival in Acute Lymphoblastic Leukemia
February 5th 2016The phase III TOWER study has been halted after an independent panel determined that blinatumomab (Blincyto) improved overall survival versus standard chemotherapy in patients with Philadelphia chromosome–negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
FDA Approves Single-Dose Fosaprepitant for CINV
February 4th 2016The FDA approved single-dose fosaprepitant dimeglumine (Emend for injection) in combination with other antiemetic agents for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC), according to Merck, the developer of the drug.
World Cancer Day Aims to Unite Millions to Increase Awareness, Reduce Global Burden
February 4th 2016With more than 8 million cancer deaths worldwide every year, the Union for International Cancer Control hopes to encourage both groups and individuals to reflect on how they can help reduce the global burden of cancer on February 4, World Cancer Day.
Osimertinib Approved in Europe for EGFR T790M-Mutant NSCLC
February 3rd 2016The European Commission has granted a conditional marketing authorization to osimertinib for patients with locally advanced or metastatic EGFR T790M mutation-positive non–small cell lung cancer, regardless of prior treatment with EGFR TKI.
FDA Issues Complete Response Letter for Immunotherapy MCNA in Bladder Cancer
February 3rd 2016The FDA issued a complete response letter to Telesta Therapeutics informing the company that its biologics license application for MCNA in bladder cancer would not be approved and that an additional phase III clinical trial was needed to adequately evaluate the immunotherapy.