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.
Amgen Seeks FDA Approval for Blinatumomab in ALL
September 22nd 2014A Biologics License Application has been submitted to the FDA for the bispecific T-cell engager (BiTE) antibody blinatumomab as a treatment for adult patients with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)
FDA Grants Special Protocol Assessment to Phase III Ublituximab/Ibrutinib Study
September 21st 2014TG Therapeutics has reached an agreement with the FDA regarding a Special Protocol Assessment for a phase III clinical trial exploring ublituximab in combination with ibrutinib for the treatment of patients with chronic lymphocytic leukemia.
Differences Identified Between What Medicare Covers and What Patients with Cancer Want
September 15th 2014Does Medicare coverage for patients with cancer match up to what they actually want covered? There appears to be a mismatch between covered benefits and beneficiary preferences that involves quality of life and financial burden of care, according to a study from Duke University.
UCLA Researcher Provides Insight Into the Impact of Pembrolizumab in Melanoma
September 13th 2014To gain further insight into the approval of pembrolizumab, OncLive interviewed John Glaspy, MD, MPH, from the Jonsson Comprehensive Cancer Center at UCLA, where research into the novel drug was conducted.
More Hospital-Based Cancer Programs Offering Patient Financial Advocacy Services
September 11th 2014Increasingly, payers and patients are demanding that hospital-based oncology practices take a patient-centered approach in delivering care, with a specific focus on offering some form of financial assistance services to their patients, according to findings from the Association of Community Cancer Centers' "2014 Trends in Cancer Programs" survey.
New ASCO/CCO mCRPC Treatment Guideline Incorporates Latest Approved Drugs
September 8th 2014ASCO and CCO have released an updated guideline focused on the treatment of men with mCRPC that incorporates information about 6 recently approved drugs that have significantly changed the therapeutic landscape.
Bristol-Myers Squibb Challenges Patent on Merck's Pembrolizumab
September 5th 2014BMS has filed a lawsuit over Merck's newly approved immunotherapy drug pembrolizumab, contending that the much-heralded PD-1 inhibitor will infringe upon patents that Bristol-Myers holds on the groundbreaking technology.
Converting From Manual to Electronic Transactions Could Save Healthcare Industry Billions
September 4th 2014A report issued by the Council for Affordable Quality Healthcare (CAQH) suggests that if providers and health plans converted fully from manual to electronic transactions, it could result in an additional estimated savings of $8.1 billion for the healthcare industry.
FDA Approval Sought for Lenvatinib in Differentiated Thyroid Cancer
August 31st 2014Eisai has submitted a New Drug Application for lenvatinib (E7080) as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), based on findings from the phase III SELECT trial that was presented at the 2014 ASCO Annual Meeting.
Report Identifies Shortfalls in Medicare Accountability Model
August 25th 2014How much physicians get paid is increasingly determined by a payment formula that penalizes doctors whose patients are more expensive-even when those higher costs stem from services that other doctors perform says a new report from the Center for Healthcare Quality and Payment Reform.