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 Lenalidomide/Rituximab Priority Review for Indolent Non-Hodgkin Lymphoma
February 27th 2019The FDA has granted a priority review designation to a supplemental new drug application for the R2 regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) for use in patients with previously treated follicular lymphoma and marginal zone lymphoma.
Frontline Olaparib Maintenance Improves PFS in BRCA+ Pancreatic Cancer
February 26th 2019Frontline maintenance therapy with olaparib significantly reduced the risk of disease progression or death versus placebo in patients with germline BRCA-mutated metastatic adenocarcinoma of the pancreas, according to findings from the phase III POLO trial.
Molecular Testing Needed to Inform CRC Treatment Decisions
February 25th 2019Michael Overman, MD, highlights data from pivotal trials presented at the 2019 Gastrointestinal Cancers Symposium and discusses where research efforts should be focused to improve the treatment of patients with colorectal cancer.
FDA Approves TAS-102 for Gastric/GEJ Cancer
February 25th 2019The FDA has approved TAS-102 (trifluridine/tipiracil; Lonsurf) for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
City of Hope Awarded Lymphoma SPORE Grant From NCI
February 22nd 2019An international leader in finding new, innovative treatments for lymphoma patients, City of Hope announced today that it has received its third lymphoma Specialized Programs of Research Excellence grant from the National Cancer Institute.
Research Finds Rivaroxaban Significantly Reduces Blood Clots in Patients With Cancer
February 21st 2019Cleveland Clinic research has found that the blood thinner rivaroxaban significantly reduces venous thromboembolism (VTE)—a blood clot in the venous system—and VTE-related death for outpatient, high-risk cancer patients while they are taking the oral anticoagulant.
Novel Frontline Regimen Improves PFS in Older Patients With MCL
February 21st 2019The 4-drug combination of rituximab, bendamustine, bortezomib, and dexamethasone was found to improve progression-free survival and demonstrated a tolerable safety profile as frontline treatment for patients with mantle cell lymphoma who are ≥65 years.
Pembrolizumab Misses Primary Endpoints in HCC Trial
February 21st 2019The combination of pembrolizumab plus best supportive care for the treatment of patients with advanced hepatocellular carcinoma who were previously treated with systemic therapy did not improve progression-free or overall survival compared with placebo plus best supportive care alone, missing the coprimary endpoints of the KEYNOTE-240 trial.
FDA Grants Pembrolizumab Priority Review for Advanced SCLC
February 20th 2019The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab (Keytruda) as a treatment for patients with advanced small cell lung cancer whose disease has progressed following ≥2 prior lines of therapy.
FDA Grants Entrectinib Priority Review for NTRK+ Tumors and ROS1+ NSCLC
February 20th 2019The FDA has granted a priority review designation to a new drug application for entrectinib as a treatment for select adult and pediatric patients with NTRK fusion–positive locally advanced or metastatic solid tumors, as well as patients with metastatic ROS1-positive non–small cell lung cancer.
Bevacizumab Biosimilar Approved in Europe
February 20th 2019The European Commission has approved PF-06439535 (Zirabev), a bevacizumab (Avastin) biosimilar for the treatment of patients with metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic, or recurrent non–small cell lung cancer, advanced and/or metastatic renal cell cancer, and persistent recurrent or metastatic carcinoma of the cervix.