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.
Japanese Approval Sought for Fruquintinib in Previously Treated Metastatic Colorectal Cancer
October 2nd 2023A new drug application seeking the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer has been submitted to Japan’s Ministry of Health, Labour, and Welfare.
FDA Grants Fast Track Designation to AVB-001 for R/R Platinum-Resistant Ovarian Cancer
October 2nd 2023The FDA has granted fast track designation to AVB-001 for the treatment of adult patients with relapsed/refractory, platinum-resistant, high-grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.
Revumenib Meets CR/CRh End Point in KMT2A-Rearranged Relapsed/Refractory AML/ALL
October 2nd 2023Treatment with the first-in-class menin inhibitor revumenib generated complete remissions or complete remissions with partial hematological recovery in adult and pediatric patients with relapsed/refractory acute myeloid leukemia or acute lymphoblastic leukemia harboring KMT2A rearrangements.
Venetoclax/Carfilzomib/Dexamethasone Triplet Shows Early Efficacy in t(11;14)+ R/R Myeloma
September 30th 2023The addition of venetoclax to carfilzomib and dexamethasone increased response rates compared with carfilzomib plus dexamethasone alone in patients with t(11:14)-positive relapsed/refractory multiple myeloma.
Cilta-Cel Leads to High PFS Rates in Patients With Multiple Myeloma and Poor Prognostic Features
September 30th 2023Patients with multiple myeloma exhibiting poor prognostic features, such as high-risk cytogenetics, soft-tissue plasmacytoma, ISS stage III disease, and triple-class exposure, experienced significant progression-free survival benefit with ciltacabtagene autoleucel.
CD38/48 Upregulation With Tazemetostat May Overcome Daratumumab Resistance in Multiple Myeloma
September 29th 2023The EZH2 inhibitor tazemetostat may mimic the role of the KDM6A gene in upregulating CD38 and CD48 expression, suggesting that this agent could restore responses to daratumamab in patients with multiple myeloma, according to a presentation at the 20th International Myeloma Society Annual Meeting.
IberVd Elicits Durable Responses in Transplant-Ineligible, Newly Diagnosed Multiple Myeloma
September 29th 2023The combination of iberdomide plus bortezomib and dexamethasone produced deep responses with a manageable toxicity profile in patients with transplant-ineligible, newly diagnosed multiple myeloma, according to data from the phase 1/2 CC-220-MM-001 trial presented at the 2023 International Myeloma Society Annual Meeting.
Teclistamab Delivers Comparable Efficacy Between Real-World and MajesTEC-1 Myeloma Populations
September 29th 2023Treatment with teclistamab-cqyv in real-world patients with relapsed/refractory multiple myeloma elicited similar efficacy results and a comparable safety profile to findings from the phase 1/2 Majes-TEC-1 trial.
Daratumumab Plus KRd With Tandem Transplant Sustains Efficacy in High-Risk, Newly Diagnosed Myeloma
September 29th 2023Induction daratumumab, carfilzomib, lenalidomide, and dexamethasone followed by consolidation double transplant sustained efficacy and safety in patients with high-risk, newly diagnosed multiple myeloma.
FDA Grants Priority Review to Odronextamab in Relapsed/Refractory Follicular Lymphoma or DLBCL
September 29th 2023The FDA has granted priority review to the biologics license application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.
PVd Extends OS and PFS in Relapsed/Refractory Multiple Myeloma
September 28th 2023Treatment with the combination of pomalidomide, bortezomib, and dexamethasone conferred a small, statistically nonsignificant overall survival benefit compared with bortezomib plus dexamethasone in patients with relapsed/refractory multiple myeloma.
IMNN-001 Plus Neoadjuvant Chemotherapy Improves PFS in Advanced Ovarian Cancer
September 28th 2023Treatment with the interleukin-12 gene-mediated immunotherapy IMNN-001 in combination with neoadjuvant platinum chemotherapy led to an improvement in progression-free survival compared with neoadjuvant chemotherapy alone in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Physical Activity Improves Performance, Frailty Scores, and PROs in Multiple Myeloma
September 28th 2023Exercises such as resistance training and walking were safe and effective interventions that were associated with improved frailty scores in patients with multiple myeloma receiving systemic treatment.
First-Line Amivantamab Plus Lazertinib Meets PFS End Point in EGFR+ NSCLC
September 28th 2023First-line treatment with the combination of amivantamab and lazertinib resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.
Zolbetuximab Could Alter Frontline Treatment Paradigm for CLDN18.2+ Gastric/GEJ Cancer
September 28th 2023Andrew Ko, MD, FASCO, highlights what the potential approval of zolbetuximab could mean for the first-line treatment paradigm for patients with CLDN18.2-positive gastric/gastroesophageal junction adenocarcinoma and detailed other ongoing research in the gastrointestinal cancer space.
Sotorasib Plus Carboplatin/Pemetrexed Displays Activity, Safety in KRAS G12C+ NSCLC
September 28th 2023Treatment with the combination of sotorasib carboplatin, and pemetrexed produced responses and demonstrated safety in patients with KRAS G12C–mutated, advanced non–small cell lung cancer, according to data from the phase 1/2 CodeBreaK 101 trial.