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.
Pembrolizumab Approval Is Tip of the Iceberg for Immunotherapy in HNSCC
September 21st 2016Barbara A. Burtness, MD, discussed the potential role for immunotherapy in frontline head and neck cancer, as well as the possible benefit of using it in combination with standard treatments, including radiation and chemotherapy.
Expert Discusses Immense Impact of Immunotherapy in GU Cancers
September 21st 2016Elizabeth Plimack, MD, discusses some of the most impressive advancements with immunotherapy agents in the fields of renal cell carcinoma and bladder cancer, as well as remaining questions with the use of these treatments.
Raising Issues and Developing Solutions at the Ruesch Center Policy Briefing
September 21st 2016The moonshot was one of many topics discussed at a September 14 policy briefing held by the Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown Lombardi Comprehensive Cancer Center. Participants also discussed the growing cost of cancer research and the implications for policy makers, health care professionals, patients and society.
EMA Initiates Official Review of Nivolumab in Bladder Cancer
September 20th 2016The European Medicines Agency has validated a type II variation application for use of nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma who have progressed following platinum-based chemotherapy.
Study Addresses Appropriate Clinical Use of PSA Trial Data in Prostate Cancer
September 19th 2016A treatment recommendation based on reduced prostate-specific antigen failure observed from early results of randomized controlled trials is not likely to prolong survival in men with moderate-to-severe comorbidities.
Anti-CD19 CAR T-Cell Therapy Induces Significant Remission Rates in B-Cell ALL
September 19th 2016Chimeric antigen receptor T-cell therapy targeting CD19 demonstrated a nearly 80% complete remission rate across relapsed/refractory B-cell acute lymphoblastic leukemia patients with multiple levels of disease burden.
CHMP Issues Positive Opinion for Palbociclib in HR+/HER2- Breast Cancer
September 17th 2016The Committee for Medicinal Products for Human Use has recommended approval of palbociclib for patients with HR-positive, HER2-negative metastatic breast cancer, either in combination with an aromatase inhibitor in the frontline setting, or combined with fulvestrant after progression on endocrine therapy.
CHMP Adopts Positive Opinion for Olaratumab in Soft Tissue Sarcoma
September 16th 2016The Committee for Medicinal Products for Human Use has recommended approval of the PDGFRα antagonist olaratumab for use in combination with doxorubicin for patients with advanced soft tissue. sarcoma who are not good candidates for radiotherapy or surgery.
EC Approves Cabozantinib for Renal Cell Carcinoma
September 15th 2016The European Commission has approved cabozantinib for the treatment of patients with advanced renal cell carcinoma after the failure of VEGF-targeted therapy, according to Exelixis and Ipsen, the manufacturers of the multikinase inhibitor.
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.