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.
Enfortumab Vedotin Emerging as Post-Immunotherapy Option in Bladder Cancer
August 9th 2018Jonathan E. Rosenberg, MD, discusses the promise of enfortumab vedotin in patients with bladder cancer who previously received a checkpoint inhibitor, and reflects on the rapid pace of change in the urothelial cancer landscape.
Cleveland Clinic Researchers Receive $4.7M NIH Grant to Prevent Cancer-Associated Thrombosis
August 8th 2018The National Heart, Lung and Blood Institute, part of the National Institutes of Health, awarded a $4.7 million grant to Cleveland Clinic to study the prevention of life-threatening, cancer-associated blood clots.
FDA Grants Novel Triplet Breakthrough Designation in BRAF+ mCRC
August 7th 2018The FDA has granted a breakthrough therapy designation to the combination of encorafenib (Braftovi), binimetinib (Mektovi), and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer.
FDA Grants Breakthrough Status to Lenvatinib/Pembrolizumab for Endometrial Cancer
August 2nd 2018The FDA has granted a breakthrough therapy designation to the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.
EU Approves Trastuzumab Biosimilar for HER2+ Breast, Gastric Cancers
August 1st 2018PF-05280014 (Trazimera), a biosimilar for trastuzumab (Herceptin), has been approved for use in the European Union to treat patients with HER2 overexpressing metastatic or early breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Iobenguane I-131 for Rare Neuroendocrine Tumors
July 31st 2018The FDA has approved iobenguane I-131 (Azedra) for adult and pediatric patients aged ≥12 years with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.