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 Panel Votes Against Apaziquone in Bladder Cancer
September 14th 2016The FDA’s Oncologic Drugs Advisory Committee voted 14-0 against approving apaziquone (EOquin; Qapzola) for intravesical instillation immediately following transurethral resection in patients with non-muscle invasive bladder cancer.
Expert Urges Revisiting PSA Screening After Pivotal Trial Update
September 13th 2016After updated findings from the landmark Prostate, Lung, Colorectal, and Ovary screening trial were presented earlier this year, members of the oncology community strongly suggested that the United States Preventative Services Task Force revise its views on prostate-specific antigen screening for patients with prostate cancer.
Tesaro Initiates Rolling Submission for Niraparib in Ovarian Cancer
September 12th 2016The FDA has granted a fast track designation to niraparib, allowing the initiation of a rolling submission of data for potential approval for the PARP inhibitor as a treatment for women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Obesity Paradox in RCC: Improved OS for Patients With High BMI
September 9th 2016Evidence has demonstrated that obesity is a risk factor for clear cell renal cell carcinoma; however, a new report suggests that a high body mass index is a prognostic factor for improved survival in patients with metastatic RCC who have received targeted therapy.
Expert Discusses Evolving Roles of Cabozantinib, Nivolumab in RCC
September 8th 2016Jorge A. Garcia, MD, discusses the final survival data from the phase III METEOR trial, which was the basis for cabozantinib's (Cabometyx's) FDA approval, as well as the role the agent will now play along with nivolumab (Opdivo) in advanced RCC.
CVS Cuts In-House Dispensaries Out of Part D Plan
September 2nd 2016A move by CVS Health to place in-house physician dispensaries out-of-network for purposes of Medicare Part D drug payment would force hundreds of thousands of cancer patients across the country to find alternate sources for their oral oncolytic drugs.
FDA Approves Blinatumomab for Pediatric Acute Lymphoblastic Leukemia
September 2nd 2016The FDA has granted an accelerated approval to blinatumomab (Blincyto) for the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.