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.
Axicabtagene Ciloleucel Approaches EU Approval for DLBCL, PMBCL
June 29th 2018The European Medicines Agency’s CHMP has recommended approval of axicabtagene ciloleucel (axi-cel; Yescarta) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
EMA Committee Recommends CPX-351 Approval for 2 AML Types
June 29th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of CPX-351, a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes.
EU Panel Backs Adjuvant Nivolumab for Melanoma
June 29th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab (Opdivo) as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease
Tisagenlecleucel Nears European Approval for DLBCL, ALL
June 29th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of tisagenlecleucel for the treatment of either adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.
Neratinib Approaches EU Approval for HER2+ Breast Cancer
June 29th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of neratinib for the extended adjuvant treatment of adult patients with early stage hormone receptor–positive, HER2-overexpressed/amplified breast cancer following postoperative trastuzumab.
FDA Approves Binimetinib/Encorafenib for BRAF+ Melanoma
June 27th 2018The FDA has approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.
Olaparib Improves PFS as Frontline Maintenance in Ovarian Cancer
June 27th 2018Olaparib tablets reduced the risk of disease progression or death compared with placebo as frontline maintenance therapy for women with BRCA-positive advanced ovarian cancer, according to findings from the randomized phase III SOLO-1 trial.
Palbociclib Misses OS Endpoint in PALOMA-3 Breast Cancer Study
June 25th 2018The combination of palbociclib (Ibrance) and fulvestrant (Faslodex) failed to improve overall survival compared with fulvestrant and placebo in the phase III PALOMA-3 trial for patients with HR-positive, HER2-negative metastatic breast cancer.
FDA Grants Ibrutinib/Rituximab Priority Review for Waldenstrom Macroglobulinemia
June 25th 2018The FDA has granted a priority review to a supplemental new drug application for ibrutinib for use in combination with rituximab as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.
FDA Accepts Application for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC
June 22nd 2018The FDA has accepted a supplemental biologics license application for the combination of nivolumab plus ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.