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.
Belantamab Mafodotin Myeloma Application Fast-Tracked in EU
February 3rd 2020The European Medicines Agency has validated a Marketing Authorization Application for belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor, and a CD38-directed monoclonal antibody.
Dinutuximab Misses Survival Endpoint in Small Cell Lung Cancer
February 3rd 2020The addition of dinutuximab injection to irinotecan did not improve overall survival compared with irinotecan or topotecan alone in patients with relapsed/refractory small cell lung cancer, missing the primary endpoint of the phase II/III DISTINCT trial.
Darolutamide Nears EU Approval for Nonmetastatic CRPC
February 1st 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease.
EU Panel Recommends Frontline Venetoclax/Obinutuzumab in CLL
January 31st 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the fixed-dose combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia.
Tucatinib Takes Step Toward EU Approval in HER2+ Breast Cancer
January 31st 2020The European Medicines Agency has validated a Marketing Authorization Application for tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have received ≥2 prior anti-HER2 treatment regimens.
Ruxolitinib Combo Elicits Clinical Activity in Polycythemia Vera and Myelofibrosis
January 30th 2020The combination of ruxolitinib (Jakafi) plus low-dose pegylated interferon-a2 demonstrated an improvement in peripheral blood cell counts bone marrow cellularity and fibrosis, and symptom burden with acceptable toxicity in patients with polycythemia vera or proliferative myelofibrosis.
Darolutamide Improves Survival in Nonmetastatic CRPC
January 30th 2020Darolutamide plus androgen deprivation therapy (ADT) led to a significant improvement in overall survival (OS) compared with placebo and ADT in patients with nonmetastatic castration-resistant prostate cancer, according to results from a preplanned final OS analysis of the phase III ARAMIS trial.
Novel Surgical Technique Alleviates Adverse Events After Amputation in Patients With Cancer
January 30th 2020Thomas J. Scharschmidt, MD, MBOE, discusses the use of targeted muscle reinnervation for amputee patients with cancer as well as therapeutic advances in sarcoma and tenosynovial giant cell tumor.
FDA Schedules ODAC Meeting on Ramucirumab/Erlotinib in Frontline EGFR+ NSCLC
January 30th 2020The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for February 26, 2020, to discuss data supporting a supplemental biologics license application for intravenous ramucirumab injection for use in combination with erlotinib in the frontline treatment of patients with metastatic non–small cell lung cancer whose tumors harbor EGFR Ex19del or Ex21 substitution mutations.
Japanese Approval Sought for Cabozantinib in Advanced HCC
January 30th 2020A new drug application has been filed with the Japanese Ministry of Health, Labor and Welfare for manufacturing and marketing approval of cabozantinib for the treatment of patients with unresectable hepatocellular carcinoma following progression on prior systemic therapy.
FDA Grants Priority Review to Selpercatinib for RET Fusion+ NSCLC and Thyroid Cancers
January 29th 2020The FDA has granted a priority review designation to a new drug application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion–positive non–small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion–positive thyroid cancer.
CMS Expands Coverage of NGS Diagnostic Tests for Germline Ovarian, Breast Cancers
January 29th 2020The Centers for Medicare & Medicaid Services has expanded coverage of laboratory diagnostic tests that utilize next-generation sequencing that have been approved or cleared by the FDA for use in patients with germline ovarian or breast cancers.