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.
Osimertinib Shows Efficacy in CNS and Leptomeningeal Mets in EGFR+ NSCLC
February 21st 2020Osimertinib, at 160 mg daily, demonstrated efficacy in the central nervous system and a manageable safety profile in patients with EGFR-mutant advanced non–small cell lung cancer who have leptomeningeal metastases.
Precision Medicine Approaches Evolving With CDK4/6, PI3K Inhibitors in HR+ Breast Cancer
February 21st 2020Sara Tolaney, MD, MPH, reflects on the encouraging findings observed with CDK4/6 inhibitors in combination with endocrine therapy in the treatment of patients with hormone receptor-positive, HER2-negative breast cancer.
Panobinostat Combo Shows Early Promise in Myelofibrosis and Polycythemia Vera
February 21st 2020The combination of panobinostat and ruxolitinib demonstrated efficacy and a tolerable safety profile as a treatment for patients with primary myelofibrosis and post-polycythemia vera–related myelofibrosis and post essential thrombocythemia–related myelofibrosis.
Ongoing Studies May Clarify Role of ADCs in Gastric Cancer and CRC
February 20th 2020The approval of fam-trastuzumab deruxtecan-nxki in HER2-positive breast cancer is generating hopes that similar strategies also may be effective against HER2-expressing gastric and colorectal cancers, according to a panel of experts in gastrointestinal malignancies.
FDA Grants Priority Review to Selinexor for Relapsed/Refractory DLBCL
February 20th 2020The FDA has granted a priority review designation to a supplemental new drug application for selinexor as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma, not otherwise specified, who have received ≥2 prior therapies.
FDA Issues Complete Response Letter for Updated Pembrolizumab Dosing Schedule
February 20th 2020The FDA has issued a complete response letter to 6 supplemental biologics license applications that would have updated the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions across multiple indications.
FDA Grants Breakthrough Designation to Frontline Enfortumab Vedotin/Pembrolizumab in Bladder Cancer
February 20th 2020The FDA has granted a breakthrough therapy designation to the combination of enfortumab vedotin-ejfv and pembrolizumab as a first-line treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy.
FDA Grants Priority Review to Frontline Atezolizumab for Advanced PD-L1-High NSCLC
February 19th 2020The FDA has granted a priority review designation to a supplemental biologics license application for single-agent atezolizumab as a frontline treatment for patients with advanced nonsquamous or squamous non–small cell lung cancer without EGFR or ALK mutations who have high PD-L1 expression on tumor cells or tumor-infiltrating immune cells, defined as TC3/IC3 wild-type.
Renowned Gastrointestinal Radiation Oncologist Hired to Lead Clinical Cancer Research at Mount Sinai
February 19th 2020Karyn Aalami Goodman, MD, MS, an internationally recognized expert on gastrointestinal cancers, has joined the Icahn School of Medicine at Mount Sinai as Associate Director for Clinical Research at The Tisch Cancer Institute. She is also Professor and Vice Chair for Research and Quality in the Department of Radiation Oncology.
Nivolumab/Cabiralizumab Combo Misses PFS Endpoint in Pancreatic Cancer
February 19th 2020The combination of nivolumab and the investigational CSF-1R inhibitor cabiralizumab with and without chemotherapy did not improve progression-free survival compared with chemotherapy alone in patients with advanced pancreatic cancer, missing the primary endpoint of a phase II trial (NCT03336216).
Nodal Involvement Impacts Surgical Management of Axilla in Breast Cancer
February 19th 2020Hernan Vargas, MD, FACS, discusses the criteria that are used to determine the appropriate surgical intervention for patients with node-positive breast cancer and shared questions that still need to be addressed in the space.