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.
ASTRO Guideline Provides Clarity on Radiation Use in Soft Tissue Sarcoma
August 30th 2021The American Society for Radiation Oncology released a new clinical guideline, which was also published in Practical Radiation Oncology, outlined recommendations and patient selection for optimal radiation dosing, sequencing, and treatment planning for patients with soft tissue sarcoma.
Nivolumab and Tumor-Infiltrating Lymphocyte Regimen Elicits Activity in Metastatic NSCLC
August 27th 2021Nivolumab followed by tumor-infiltrating lymphocyte therapy and maintenance nivolumab demonstrated a suitable safety profile and antitumor activity in patients with metastatic non–small cell lung cancer.
Tafasitamab Plus Lenalidomide Approved in Europe for Relapsed/Refractory DLBCL
August 27th 2021The European Commission has granted a conditional marketing authorization to tafasitamab plus lenalidomide followed by single-agent tafasitamab for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.
Pembrolizumab Approved in Japan for Select Breast Cancer and Colorectal Cancer
August 26th 2021The Japan Pharmaceuticals and Medical Devices Agency has approved the use of pembrolizumab in the treatment of patients with PD-L1–positive, hormone receptor–negative and HER2-negative, inoperable or recurrent breast cancer, and for single-agent use in patients with unresectable, advanced, or recurrent microsatellite instability–high colorectal cancer.
Focus on Health Equity in Cancer Care Leads to National Recognition
August 26th 2021Montefiore Einstein Cancer Center has once again earned national recognition for its quality of care studies leading to enhanced patient care, its strong cancer screening and early detection initiatives, and its exceptional support services.
FDA Green Lights Companion Diagnostic for Ivosidenib in IDH1-Mutant Cholangiocarcinoma
August 26th 2021The FDA has approved the Oncomine Dx Target Test, developed by Thermo Fisher Scientific, for use as a companion diagnostic to identify patients with IDH1-mutated cholangiocarcinoma who may be eligible to receive the newly approved IDH1 inhibitor ivosidenib.
Roxadustat Shows Activity Against Chemotherapy-Induced Anemia in Non-Myeloid Malignancies
August 26th 2021The first-in-class small molecule HIF-PHI inhibitor roxadustat demonstrated promising efficacy with favorable tolerability when used in the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies, meeting the primary end point of the phase 2 WHITNEY trial.
Silmitasertib Gets Fast Track Status for Recurrent Sonic Hedgehog–Driven Medulloblastoma
August 25th 2021The FDA has granted a fast track designation to the highly selective CK2 inhibitor silmitasertib as a potential therapeutic option for patients with recurrent sonic hedgehog–driven medulloblastoma
SY-5609 Under Investigation With Atezolizumab in Colorectal Cancer Subsets
August 25th 2021The highly selective and potent CDK7 inhibitor SY-5609 is being tested in combination with atezolizumab in patients with molecularly defined subsets of colorectal cancer, as one of the cohorts of the ongoing, phase 1/1b INTRINSIC trial.
Clinicopathologic and Genomic Testing Confirm Differences in Pediatric Melanocytic Tumors
August 24th 2021Distinct subgroups of pediatric melanocytic lesions, which were identified by an integrated clinicopathologic and genomic analysis, were found to have different clinical behaviors, suggesting that this combined diagnostic modality could inform individualized diagnoses and treatments for patients with these rare malignancies.
Phase 2 Trial of Bintrafusp Alfa in Frontline Biliary Tract Cancer Discontinued
August 24th 2021Merck KGaA, Darmstadt, Germany has decided to discontinue the phase 2 INTR@PID BTC 055 trial examining bintrafusp alfa plus gemcitabine and cisplatin in the frontline treatment of patients with locally advanced or metastatic biliary tract cancer.
Second-Line Tisagenlecleucel Misses EFS End Point in Aggressive B-cell Non-Hodgkin Lymphoma
August 24th 2021The CAR T-cell therapy tisagenlecleucel did not significantly improve event-free survival compared with standard of care when used in the second-line treatment of patients with aggressive B-cell non-Hodgkin lymphoma who had primary refractory disease or who relapsed within 12 months of frontline treatment.