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.
Real-World Data With Niraparib Show Lower AEs Vs ENGOT-OV6/NOVA Trial in Ovarian Cancer
November 8th 2018Real-world incidences of nausea, thrombocytopenia, and fatigue were markedly lower in patients with platinum-sensitive, recurrent ovarian cancer receiving a starting 200-mg daily dose of niraparib versus those enrolled on the phase III ENGOT-OV6/NOVA trial.
FDA Grants Selinexor Fast Track Designation for Relapsed/Refractory DLBCL
November 8th 2018The FDA has granted a fast track designation to selinexor for the treatment of patients with previously treated diffuse large B-cell lymphoma who are ineligible to receive high-dose chemotherapy with stem cell rescue or CAR T-cell therapy.
CAR T-Cell Therapies Moving to Outpatient Setting
November 8th 2018The high durable response rates seen with CAR T-cell therapies have helped fill a high unmet need for patients with relapsed/refractory diffuse large B-cell lymphoma, with questions remaining on the optimal way to use these agents following the FDA approval of 2 therapies in the past year.
PFS Improved With Maintenance Rucaparib in Recurrent Ovarian Cancer Irrespective of Prior Chemo
November 7th 2018In patients with platinum-sensitive recurrent ovarian cancer, the PARP inhibitor rucaparib as maintenance treatment improved progression-free survival versus placebo, despite the number of chemotherapy regimens.
FDA Approves Elotuzumab Triplet for Myeloma
November 7th 2018The FDA has approved elotuzumab for use in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.
FDA Approval Sought for Brentuximab Vedotin in Frontline CD30+ PTCL
November 6th 2018A supplemental biologics license application has been submitted to the FDA for the use of brentuximab vedotin (Adcetris) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
Venetoclax Plus Obinutuzumab Improves PFS in Frontline CLL
November 1st 2018The combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) reduced the risk of disease progression or death versus obinutuzumab plus chlorambucil in treatment-naïve patients with chronic lymphocytic leukemia with comorbidities.
Expert Highlights Immunotherapy/Chemotherapy Combos in TNBC
October 31st 2018The efficacy of combination therapy with a checkpoint inhibitor and chemotherapy has been proved in the triple-negative breast cancer space, and the additive and early toxicity may be worth the survival benefit, according to Lisa A. Carey, MD.