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.
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.
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.