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.
Axicabtagene Ciloleucel Approved in Japan for Relapsed/Refractory LBCL
January 22nd 2021January 22, 2021 — The Japan Ministry of Health, Labour and Welfare has approved the CAR T-cell therapy axicabtagene ciloleucel for use in the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas.
FDA Grants Priority Review to Retifanlimab for Squamous Cell Carcinoma of the Anal Canal
January 21st 2021January 21, 2021 - The FDA has granted priority review to a biologics license application for retifanlimab for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who were intolerant of or who had progressed on platinum-based chemotherapy.
HER2-Directed Antibody-Drug Conjugates May Carve Out a Place in NSCLC Landscape
January 21st 2021The current standard of care for patients with non–small cell lung cancer does not include therapies targeting HER2, a mutation that occurs in up to 4% of cases. However, data from recent studies of antibody-drug conjugates directed at HER2 activity are generating excitement about the potential utility of ADCs in this space.
Adult Nonmalignant Hematology Is an Endangered Field That Merits Protection
January 21st 2021The scope of adult nonmalignant hematology can be broad and includes thrombotic and hemorrhagic disorders, transfusion medicine, hemoglobin disorders including sickle cell disease and thalassemia, anemia, thrombocytopenia, leukocytosis, leukopenia, and disorders of iron metabolism.
New Designations and Efficacy Demonstrations Push the EGFR+ NSCLC Paradigm Forward
January 20th 2021Timothy F. Burns, MD, PhD, dissects the role of osimertinib in EGFR-mutant NSCLC, sheds light on remaining questions in the field, and speaks to some of the most intriguing emerging agents in the space.
Trastuzumab Deruxtecan Approved in Europe for HER2+ Metastatic Breast Cancer
January 20th 2021January 20, 2021 - The antibody-drug conjugate trastuzumab deruxtecan has been granted conditional approval in the European Union for use as a single agent in the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more HER2-based regimens.
FDA Grants Priority Review to Adjuvant Nivolumab for Resected Esophageal or GEJ Cancer
January 20th 2021The FDA has granted priority review to a supplemental biologics license application for nivolumab for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation treatment.
PFS Deserves More Than Surrogate Status as a Clinical Trial End Point
January 20th 2021Although recent benefits do not pertain to all cancers and “cure” remains a relatively uncommon event, oncologists have an increasing number of molecularly targeted and immunotherapeutic strategies to employ based on objectively meaningful clinical trial outcomes.
High-Dose Y-90 Pushes the HCC Paradigm Toward Personalized, Multidisciplinary Care
January 20th 2021Beau Toskich, MD, discusses the potential of TheraSphere as a therapy in hepatocellular carcinoma, the importance of utilizing a multidisciplinary approach among novel radiation oncology agents, and his hope for a future prospective clinical trial evaluating Y-90.
Emerging Strategies Seek to Build on Radiation Benefits in Lung Cancer
January 19th 2021Katie Keane, MD, highlights the evolving role of stereotactic body radiation therapy in the treatment of patients with stage I lung cancer, the utilization of immunotherapy with chemoradiation in stage III disease, and research evaluating radiation in those with oligometastatic disease.
FDA Grants Premarket Approval to Diagnostic Breast Cancer Imaging Technology
January 19th 2021January 19, 2021 - The FDA’s Center for Devices and Radiological Health has granted premarket approval to diagnostic breast cancer imaging technology developed by Seno Medical Instruments to assist in the differentiation between benign and malignant breast lesions in patients.
Expert Sees Need for Better Guideline Adherence in NSCLC
January 19th 2021At the beginning of his career as a medical oncologist in the 1990s, lung cancer specialist Rogerio C. Lilenbaum, MD, was squarely focused on diagnosing and treating his patients while translating emerging clinical research into practice.