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.
FDA Approves Radioactive Imaging Agent Axumin in Recurrent Prostate Cancer
May 27th 2016The radioactive imaging agent, fluciclovine F18 (Axumin), was approved by the FDA for use in positron emission tomography scans in men with suspected recurrence of prostate cancer whose prostate-specific antigen levels rise following prior treatment.
Gene Expression Signature Predicts Hormonal Resistance in Prostate Cancer
May 24th 2016Using the Decipher Prostate Cancer Classifier assay to predict which patients might respond to hormonal therapy has resulted in the discovery and validation of an adjuvant androgen-deprivation therapy resistance signature.
Daratumumab Approved in Europe for Multiple Myeloma
May 23rd 2016The European Commission has granted conditional marketing approval to daratumumab (Darzalex) for the treatment of patients with relapsed/refractory multiple myeloma previously treated with a proteasome inhibitor and an immunomodulatory agent who progressed on their last therapy.
IHC Staining Found Effective for ROS1+ NSCLC
May 22nd 2016The use of immunohistochemistry could be a more cost- and time-efficient first-line screening method for identifying ROS1 gene rearrangements to predict eligibility for crizotinib (Xalkori) for patients with non–small cell lung cancer compared with fluorescence in-situ hybridization.
Long-Term Data Uphold Neoadjuvant Pertuzumab Benefit in HER2+ Breast Cancer
May 19th 2016A 5-year follow-up of the phase II NeoSphere trial confirmed that patients with HER2-positive breast cancer receiving a 3-drug neoadjuvant pertuzumab regimen had better outcomes compared with patients receiving trastuzumab and docetaxel.
FDA Approves Atezolizumab in Bladder Cancer
May 18th 2016The FDA granted the PD-L1 inhibitor atezolizumab (Tecentriq) an accelerated approval as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease progressed during or after platinum-based chemotherapy, or within 12 months of receiving platinum-based chemotherapy, either before or after surgery.
Combined Vaccines Study Misses Primary Endpoint in Pancreatic Cancer
May 16th 2016A regimen combining the vaccines CRS-207 and GVAX Pancreas failed to improve overall survival versus either CRS-207 alone or chemotherapy in patients with metastatic pancreatic cancer who had failed at least 2 prior therapies.