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.
NEJM Data Highlight Blinatumomab OS Benefit in Acute Lymphoblastic Leukemia
March 2nd 2017Treatment with blinatumomab (Blincyto) led to a median overall survival of 7.7 months versus 4 months with standard chemotherapy in patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, according to results from the phase III TOWER study published in The New England Journal of Medicine.
Adjuvant Pertuzumab Succeeds in Phase III HER2+ Breast Cancer Trial
March 2nd 2017Adding pertuzumab (Perjeta) to trastuzumab (Herceptin) and chemotherapy reduced the risk of recurrence of invasive disease or death in patients with HER2-positive early breast cancer, according to findings from the phase III APHINITY study.
Ibrutinib Benefit in Waldenstrom Macroglobulinemia Sustained With Latest Data
March 2nd 2017Single-agent ibrutinib induced a response rate of 90% at a median follow-up of 18.1 months in rituximab-refractory patients with Waldenstrom macroglobulinemia, according to results from an open-label substudy of the ongoing phase III iNNOVATE trial published in The Lancet Oncology.
Carfilzomib Improves Survival in Relapsed Multiple Myeloma
March 1st 2017Carfilzomib (Kyprolis) plus dexamethasone improved overall survival by 21% versus dexamethasone plus bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma, according to findings from the phase III ENDEAVOR trial.
FDA Approves Telotristat Ethyl for Carcinoid Syndrome Diarrhea
March 1st 2017The FDA has approved telotristat ethyl (Xermelo) for use in combination with somatostatin analog (SSA) as a treatment for carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors that cannot be adequately controlled by SSA therapy alone.
FDA Grants Avelumab Priority Review for Metastatic Urothelial Carcinoma
February 28th 2017The FDA has granted a priority review to a biologics license application for avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based therapy.
Expert Discusses Optimizing Adjuvant CRT in Head and Neck Cancer
February 28th 2017Samuel Swisher-McClure, MD, discusses the results of a recent retrospective, observational cohort study that examined use and survival outcomes of adjuvant chemoradiotherapy in patients with resected locally advanced head and neck cancer.
Biomarkers Show Efficacy of Radium-223/Docetaxel Combo in mCRPC
February 28th 2017Michael J. Morris, MD, discusses a phase I/II trial in which the combination of radium-223 (Xofigo) and docetaxel had a greater effect than docetaxel alone on bone biomarkers in patients with bone-metastatic castration-resistant prostate cancer.
Rolapitant Recommended for EU Approval for CINV
February 27th 2017The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of oral rolapitant (Varuby; Varubi in US) for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy.
Daratumumab Triplets Recommended for EU Approval in Myeloma
February 25th 2017The EMA’s Committee for Medicinal Products for Human Use has recommended approval of daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy.
CHMP Recommends Dabrafenib/Trametinib Combo in BRAF+ NSCLC
February 24th 2017The EMA’s Committee for Medicinal Products for Human Use has recommended approval of the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) as a treatment for patients with advanced or metastatic BRAF V600E-mutant non-small cell lung cancer.