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.
FDA Approves Pralsetinib for RET+ Thyroid Cancers
December 1st 2020December 1, 2020 - The FDA has approved pralsetinib for the treatment of select patients with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
FDA Grants Fast Track Status to Irinotecan Liposome Injection for Second-Line SCLC
December 1st 2020December 1, 2020 — The FDA has granted a fast track designation to irinotecan liposome injection as second-line monotherapy option for patients with small cell lung cancer whose disease progressed following a platinum-based chemotherapy regimen.
FDA Approval Sought for Ublituximab/Umbralisib Combo in CLL
December 1st 2020December 1, 2020 - A rolling submission of a biologics license application to the FDA has been initiated for the CD20-directed monoclonal antibody ublituximab in combination with the PI3K-delta and CK1-epsilon inhibitor umbralisib for the treatment of patients with chronic lymphocytic leukemia.
Pandemic Heightens Stress of Cancer Diagnosis
December 1st 2020The repercussions of delays in diagnosing cancer, either through screening or the presence of early symptoms, and of required modifications in standard-of-care management paradigms in the COVID-19 era are only now beginning to be fully appreciated.
Response-Based Radiation Is Effective, Safe in Pediatric High-Risk Hodgkin Lymphoma
December 1st 2020The use of response-based consolidation coupled with radiation therapy was found to be effective and well tolerated, with low failure rates, in pediatric patients with high-risk classical Hodgkin lymphoma.
Bardia Brings Clinical Scenarios to Light Across Breast Cancer Subtypes
November 30th 2020The availability of targeted therapy, antibody-drug conjugates, and immunotherapy necessitates greater discussions regarding second-line treatment for patients with metastatic hormone receptor–positive, HER2-negative breast cancer, third-line treatment for patients with metastatic HER2-positive breast cancer, and neoadjuvant therapy for patients with locally advanced triple-negative breast cancer.
Laparoscopic Gastrectomy Is Noninferior to Open Approach in Locally Advanced Gastric Cancer
November 29th 2020Laparoscopic distal gastrectomy with D2 lymphadenectomy demonstrated comparable rates of 3-year relapse-free survival vs open distal gastrectomy in patients with locally advanced gastric cancer.
Selinexor Improves PFS in Advanced Unresectable Dedifferentiated Liposarcoma
November 25th 2020Selinexor demonstrated a statistically significant improvement in progression-free survival compared with matching placebo in patients with advanced unresectable dedifferentiated liposarcoma, following at least 2 prior treatments.
Atezolizumab/Bevacizumab Lays the Groundwork for Optimal Sequencing in HCC
November 25th 2020Milind Javle, MD, provides insight into the current treatment paradigm of advanced HCC and the potential influence ongoing research regarding biomarkers of response and novel combinations could have on the field.
SIENDO Trial of Selinexor in Endometrial Cancer Gets Green Light to Continue
November 25th 2020The phase 3 SIENDO study, which is evaluating maintenance selinexor in endometrial cancer, has been recommended by the Data and Safety Monitoring Board to continue as previously planned without the need to add additional patients to the trial or amend the study protocol, following a prespecified interim futility analysis.
Panelists Parse Out Answers to Key Questions in Hematologic Malignancies
November 25th 2020Stephen A. Strickland, MD, BS, MS, MSCI, relays insightful questions from the audience to the speakers, who provided insight into how they are navigating the evolving treatment landscape of hematologic malignancies.
Nivolumab Approved in Europe for Advanced Esophageal Cancer
November 24th 2020November 24, 2020 - The European Commission has approved nivolumab for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma following prior fluoropyrimidine- and platinum-based combination chemotherapy.
CAR T-Cell Therapy Creates Opportunities for Individualized Treatment in MCL
November 24th 2020Alan P. Z. Skarbnik, MD, highlights how treatment decisions in mantle cell lymphoma have become more nuanced since the FDA approval of the CAR T-cell therapy brexucabtagene autoleucel in the relapsed/refractory setting.