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.
Real-World Analysis Shows Low Use of Ovarian Suppression in Premenopausal HR+/HER2+ Breast Cancer
January 9th 2023Maryam Lustberg, MD, MPH, discusses key results from a retrospective analysis of ovarian suppression in HR–positive, HER2-positive breast cancer, the importance of assessing real-world practice patterns, and the need for continued study of other predictive biomarkers for endocrine therapy in this population.
Neoadjuvant SHR-1701 Increases Response, Resectability in Stage III Unresectable NSCLC
January 8th 2023Neoadjuvant treatment with SHR-1701 with or without chemotherapy followed by surgery or radiotherapy induced responses in more than half of patients with stage III unresectable non–small cell lung cancer and increased resectability in those assigned to definitive surgery.
Pexidartinib With Surgery Proves Potential Benefit for Patients With Tenosynovial Giant Cell Tumors
January 7th 2023R. Lor Randall, MD, FACS, discusses the outcomes of combining surgery and pexidartinib in patients with tenosynovial giant cell tumors, what investigators still need to learn about sequencing the CSF1R inhibitor around surgery, and what the combination approach could mean for patients with TGCT.
Developmental FGFR Inhibitors Are Active in FGFR+ Cholangiocarcinoma and Urothelial Carcinoma
January 6th 2023Mitesh J. Borad, MD, explains how FGFR alterations influence treatment strategies in cholangiocarcinoma and urothelial cancer, discusses the FGFR resistance mechanisms that are prompting further research in this area, and highlights the rationale for the KN-4802 trial.
Japan Approves Durvalumab/Tremelimumab Combo for HCC and Advanced NSCLC
January 6th 2023Japan has approved durvalumab monotherapy and durvalumab plus tremelimumab for unresectable hepatocellular carcinoma, durvalumab plus tremelimumab and chemotherapy for unresectable, advanced, or recurrent non–small cell lung cancer, and durvalumab plus chemotherapy for curatively unresectable biliary tract cancer.
Obe-cel Provides Favorable Safety Profile, Expands Potential Treatment Options in B-ALL
January 6th 2023Paul J. Shaughnessy, MD, discusses the unique properties of obecabtagene autoleucel in B-cell acute lymphoblastic leukemia and how findings from the FELIX trial support further research into the benefits of CAR T-cell therapy in patients with hematologic malignancies.
TAVT-45 Granules Show Equivalence to Abiraterone Tablets in Metastatic Prostate Cancer
January 5th 2023Abiraterone acetate granules for oral suspension demonstrated therapeutic equivalence and comparable safety to the original formulation of abiraterone acetate in patients with metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
FDA Approves FoundationOne Liquid CDx as a Companion Diagnostic for Entrectinib
January 5th 2023The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for use with the selective TKI entrectinib. The assay identifies patients with ROS1-positive NSCLC or NTRK fusion–positive solid tumors who do not have a tissue sample available and who may be appropriate for entrectinib treatment.
HAIC-Administered FOLFOX Lengthens DFS and Provides a Tolerable Safety Profile in HCC
January 5th 2023Patients with hepatocellular carcinoma with microvascular invasion who received FOLFOX through hepatic arterial infusion chemotherapy experienced improved disease-free survival rates compared with those who received no adjuvant treatment.
Imetelstat Provides Durable Transfusion Independence in Lower-Risk MDS
January 4th 2023Significant and durable transfusion independence was achieved with imetelstat vs placebo in patients with lower-risk myelodysplastic syndromes who were relapsed, refractory, or ineligible for erythropoiesis-stimulating agents, meeting the primary and a key secondary end point of the phase 3 IMerge trial.
FDA Approval Sought for Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma
January 4th 2023A biologics license application has been submitted to the FDA seeking the approval of cosibelimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
FDA Grants Breakthrough Device Designation to OverC Multi-Cancer Detection Blood Test
January 4th 2023The FDA has granted a breakthrough device designation to the OverC Multi-Cancer Detection Blood Test for the early detection of cancers including esophageal, liver, lung, ovarian, and pancreatic in adults aged to 50 to 75 years with average risk.
EMA Validates Type II Application for Trastuzumab Deruxtecan in Advanced HER2-Mutated NSCLC
January 4th 2023The European Medicines Agency has validated an application for the use of trastuzumab deruxtecan for adults with previously treated unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations.
N-803 Plus BCG Generates Strong, Durable Response in Non–Muscle Invasive Bladder Cancer
January 4th 2023N-803, a novel IL-15 superagonist, in combination with intravesical Bacillus Calmette–Guérin induced an overall response in more than two-thirds of patients with non–muscle invasive bladder cancer.
EMA Committee Advises Against Approval of Omburtamab for Neuroblastoma
January 3rd 2023The European Committee for Medicinal Products for Human Use has announced that it does not support the marketing authorization of omburtamab for the treatment of patients with central nervous system/leptomeningeal metastasis from neuroblastoma.
Glofitamab Plus R-CHOP Displays Tolerable Safety Profile in Treatment-Naïve DLBCL
January 3rd 2023Max S. Topp, MD, highlights the rationale for studying bispecific antibodies in newly diagnosed diffuse large B-cell lymphoma, how the safety profile of glofitamab plus R-CHOP contributes to its potential for outpatient administration, and where future directions with this research may lead.