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.
Analysis Explores Continuing Anti-PD-1 Therapy Past Progression in Melanoma
February 17th 2018Investigators with the FDA’s Center for Drug Evaluation and Research and Oncology Center of Excellence conducted a pooled analysis of all trial reports and data marketing applications for the use of anti–PD-1 antibodies alone or in combination to treat patients with unresectable or metastatic melanoma.
FDA Panel to Review Blinatumomab Application for MRD-positive ALL
February 16th 2018The FDA's Oncologic Drugs Advisory Committee is slated to review a supplemental biologics license application for the use of blinatumomab for the treatment of patients with minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.
Bristol-Myers Squibb Gains NKTR-214 Access in Nektar Collaboration
February 15th 2018Bristol-Myers Squibb and Nektar Therapeutics have announced plans to jointly develop and market combinations of the CD122-biased cytokine NKTR-214 with nivolumab (Opdivo) or nivolumab plus ipilimumab (Yervoy) across for 20 indications in 9 tumor types.
Pembrolizumab Plus Axitinib Active in Frontline RCC
February 12th 2018Antitumor activity of the combination of axitinib (Inlyta) and pembrolizumab (Keytruda) is superior to that expected from axitinib or PD-1/PD-L1 pathway inhibitor monotherapy in treatment-naïve patients with advanced renal cell carcinoma.
Cabozantinib Proves Superior to Sunitinib in All Subgroups Examined in CABOSUN
February 12th 2018Cabozantinib (Cabometyx) improved progression-free survival as initial systemic therapy across subgroups of patients with intermediate- and poor-risk advanced RCC enrolled in the randomized phase II CABOSUN trial.
FDA Approves Abiraterone for High-Risk Prostate Cancer
February 8th 2018The FDA has approved abiraterone acetate in combination with prednisone and androgen deprivation therapy for high-risk patients with metastatic hormone-naïve prostate cancer or newly-diagnosed metastatic hormone-sensitive prostate cancer.