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.
FDA Grants Priority Review to Pexidartinib for Tenosynovial Giant Cell Tumor
February 6th 2019The FDA has granted a priority review designation to a new drug application for the investigational, small molecule, CSF1R receptor inhibitor pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.
Isatuximab Triplet Improves PFS in Relapsed/Refractory Myeloma
February 5th 2019Isatuximab in combination with pomalidomide (Pomalyst) and low-dose dexamethasone was shown to prolong progression-free survival compared with pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma.
FDA Approval Sought for Adjuvant T-DM1 in High-Risk HER2+ Breast Cancer
February 5th 2019Genentech has completed its FDA submission of a supplemental Biologics License Application for ado-trastuzumab emtansine as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.
Further Evidence Needed Supporting Clinical Utility of Liquid Biopsies in GI Cancers
February 5th 2019John Strickler, MD, discusses how liquid biopsies are being used to help guide treatment decisions for patients with GI cancers and shed light on other research efforts that are being made to improve outcomes.
EU Panel Recommends Pembrolizumab/Chemo Combo in Squamous NSCLC
February 4th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for first-line treatment with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel in patients with metastatic squamous non–small cell lung cancer.
EU Panel Backs Frontline Atezolizumab Regimen in NSCLC
February 2nd 2019The European Medicine’s Agency Committee for Medicinal Products for Human Use has recommended approval for the frontline combination of atezolizumab, bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer.
Dacomitinib Approaches EU Approval for EGFR+ NSCLC
February 2nd 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of dacomitinib for the frontline treatment of adult patients with metastatic non–small cell lung cancer with EGFR-activating mutations.
Roswell Park Researchers Propose 2 New Strategies for Treating Pancreatic Cancer
February 1st 2019In a pair of new studies, researchers from Roswell Park Comprehensive Cancer Center outline strategies for overcoming pancreatic cancer’s resistance to treatment through approaches that exploit this cancer’s reliance on uncontrolled, or deregulated, cell proliferation.
JTCC Leading Enrollment for WIZARD Study Evaluating DSP-7888 in Recurrent Glioblastoma
February 1st 2019John Theurer Cancer Center at Hackensack Meridian Health Hackensack University Medical Center announced that it is leading enrollment worldwide for WIZARD 201G, a global Phase 2 study in glioblastoma.
NICE Recommends Tisagenlecleucel for Relapsed/Refractory DLBCL
February 1st 2019The UK’s National Institute for Health and Care Excellence has authorized the use of the CAR T-cell therapy tisagenlecleucel (Kymriah) for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma who have received ≥2 lines of chemotherapy.
ASCO Names Progress in Treating Rare Cancers as Advance of the Year
February 1st 2019Due to major advancements made within the past year in the development of new therapies for patients with difficult-to-treat, rare cancers, ASCO has selected progress in treating rare cancers as its Advance of the Year.
FDA Recommends No NDA for Tivozanib in RCC
February 1st 2019The FDA has recommended that Aveo Oncology should not submit a new drug application for tivozanib with the preliminary overall survival data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma.
FDA Expands Pemetrexed Approval for Frontline Pembrolizumab/Chemo Combo in NSCLC
January 31st 2019The FDA has expanded the indication for pemetrexed in combination with pembrolizumab and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer without EGFR or ALK alterations.
Apalutamide Improves Survival in Metastatic Castration-Sensitive Prostate Cancer
January 31st 2019Apalutamide (Erleada) in combination with androgen deprivation therapy was found to significantly improve radiographic progression-free survival and overall survival versus placebo in patients with metastatic castration-sensitive prostate cancer.