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.
CHMP Recommends Approval of Eribulin for Advanced Liposarcoma
April 5th 2016Eribulin mesylate (Halaven) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use as a treatment for patients with advanced or unresectable liposarcoma following prior treatment with an anthracycline-based chemotherapy.
Case Study Suggests Regorafenib Remains Effective Beyond Progression for mCRC
April 5th 2016Many patients with metastatic colorectal cancer will ultimately progress on standard first- and second-line therapy while maintaining a good performance status, placing importance on the optimal use of third-line treatments.
CHMP Recommends Approval of Daratumumab for Multiple Myeloma
April 4th 2016Single-agent daratumumab (Darzalex) for the treatment of patients with relapsed/refractory multiple myeloma previously treated with a proteasome inhibitor and an immunomodulatory agent has received a positive recommendation from the Committee for Medicinal Products for Human Use.
Earlier Nab-Paclitaxel/Gemcitabine Explored in Pancreatic Cancer
April 4th 2016A bevy of clinical trials exploring the use of nab-paclitaxel (Abraxane) in various combinations and treatment settings aim to uncover future strategies for treating patients with pancreatic adenocarcinoma, which remains one of the deadliest forms of cancer.
EMA Action Brings Nivolumab Closer to First Hematology Approval
March 31st 2016The European Medicines Agency validated an application for use of nivolumab (Opdivo) for previously treated patients with classical Hodgkin lymphoma), which officially begins the centralized review process for final approval of the drug in the European Union.
Neratinib Application Delayed for HER2+ Breast Cancer
March 30th 2016Puma Biotechnology announced that it plans to delay the submission of a new drug application until mid-2016 for neratinib as an extended adjuvant treatment for patients with HER2-positive early breast cancer following a trastuzumab-based regimen.
Expert Projects 2016 FDA Approvals of Nivolumab and Pembrolizumab in Head and Neck Cancer
March 28th 2016Tanguy Seiwert, MD, discusses the impact of the CheckMate-141 trial in head and neck cancer, the importance of establishing an effective biomarker, and the significance a manageable toxicity profile may have on patients with poor performance status.