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.
Frontline Atezolizumab Regimen Approved in Europe for NSCLC
March 8th 2019The European Commission has approved and granted marketing authorization to the frontline combination of atezolizumab, bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer.
FDA Approval Sought for Venetoclax/Obinutuzumab Combo for Frontline CLL
March 7th 2019A supplemental new drug application has been filed for the combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions.
Following Encouraging Therapeutic Advances, Focus in NETs Turns to Sequencing
March 6th 2019Ana Maria Cristina De Jesus-Acosta, MD, discusses somatostatin analogs and peptide receptor radionucleotide therapy, and spoke to the discussion regarding the optimal sequence of therapy in patients with neuroendocrine tumors.
EU Panel Backs Extended Pembrolizumab Dosing Schedule for Single-Agent Indications
March 5th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a new extended dosing schedule for pembrolizumab for all of the PD-1 inhibitor’s monotherapy indications in the European Union.
Personalized Medicine Is Next Step in Castration-Resistant Prostate Cancer
March 4th 2019Raoul S. Concepcion, MD, FACS, discusses the clinical implications of the findings from the ARAMIS trial and highlights other therapies that are coming down the pike for the treatment of patients with castration-resistant prostate cancer.
EU Panel Backs Olaparib for BRCA-Mutant Advanced Breast Cancer
March 2nd 2019The European Medicine Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to olaparib tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer.
EU Panel Backs Lorlatinib for ALK+ NSCLC
March 1st 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of lorlatinib for the treatment of adult patients with ALK-positive advanced non–small cell lung cancer whose disease has progressed after alectinib or ceritinib as the first ALK TKI, or crizotinib and at least one other ALK TKI.
Mirvetuximab Soravtansine Misses Primary Endpoint in Ovarian Cancer Trial
March 1st 2019Mirvetuximab soravtansine did not improve progression-free survival compared with chemotherapy in patients with folate receptor alpha–positive, platinum-resistant ovarian cancer and in an overall patient population, missing the primary endpoint of the phase III FORWARD I trial.
FDA Approves Subcutaneous Trastuzumab Formulation for HER2+ Breast Cancer
February 28th 2019The FDA has approved subcutaneous use of trastuzumab and hyaluronidase-oysk injection in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, in combination with paclitaxel in patients with metastatic HER2-positive breast cancer as a frontline treatment, and alone for patients with metastatic disease who have received at least 1 prior chemotherapy regimen
CDK4/6 Inhibitors Carry Consistent Benefit Across HR+/HER2- Breast Cancer Settings
February 27th 2019Joseph F. Stilwill, MD, shares insight on the clinical benefit seen with CDK4/6 inhibitors in patients with advanced HR-positive, HER2-negative breast cancer and highlights ongoing research aimed at overcoming acquired resistance.
FDA Panel Votes Against Accelerated Approval of Selinexor for Myeloma
February 27th 2019The FDA’s Oncologic Drugs Advisory Committee voted against accelerated approval of a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma, recommending delaying a decision on the drug until results are available from the pivotal phase III BOSTON trial.