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.
Sacituzumab Govitecan Significantly Improves PFS Vs Chemo in HR+ Metastatic Breast Cancer
March 7th 2022Sacituzumab govitecan resulted in a statistically significant improvement in progression-free survival vs physician’s choice of chemotherapy in patients with hormone receptor–positive, HER2-negative metastatic breast cancer who previously received endocrine therapy, CDK4/6 inhibitors, and 2 to 4 lines of chemotherapy, meeting the primary end point of the phase 3 TROPiCS-02 trial.
FDA Grants Priority Review to Ivosidenib Plus Azacitidine for Previously Untreated IDH1-Mutated AML
March 7th 2022The FDA has granted priority review to a supplemental new drug application seeking the approval of ivosidenib in combination with azacitidine in the treatment of patients with previously untreated IDH1-mutated acute myeloid leukemia.
FDA Approval of Cilta-Cel Fast Tracks Multiple Myeloma Toward Curative Potential
March 7th 2022Sundar Jagannath, MBBS, discusses the significance of the FDA approval of ciltacabtagene autoleucel, important adverse effects to be aware of, and shared his thoughts on where the treatment fits into the current and future treatment paradigms.
Risk-Adaptive Approaches Offer Safer, Effective Strategies for Early-Stage HER2+ Breast Cancer
March 5th 2022The integration of HER2-targeted therapies into the treatment paradigm for patients with early-stage breast cancer, specifically the standard trastuzumab, has shifted focus away from whether patients should receive to how and when they should receive treatment with these agents.
Brain Metastases Are Now More Treatable in HER2+ Metastatic Breast Cancer
March 5th 2022The treatment of patients with HER2-positive metastatic breast cancer can now be tailored based on the presence of active central nervous system disease, due to substantial advances made in the past few years into small molecule inhibitors and macromolecule biologics.
Elacestrant Significantly Improves PFS Over SOC in Advanced ER+ Metastatic Breast Cancer
March 5th 2022Elacestrant was found to result in a statistically significant and clinically meaningful improvement in progression-free survival over standard-of-care treatment in patients with estrogen receptor–positive, HER2-negative metastatic breast cancer who previously received CDK4/6 inhibitors.
Adjuvant CDK4/6 Inhibitors Demonstrate Success in Early-Stage HR+ Breast Cancer Development
March 4th 2022CDK4/6 inhibitors in the metastatic setting have demonstrated clinical benefit in the hormone receptor–positive breast cancer population, leading to curiosity of its activity in early-stage patients and setting the stage for a handful of informative clinical trials.
Neoadjuvant Immunotherapy/Chemotherapy Combos Gain in Prominence for Early-Stage TNBC
March 4th 2022Immunotherapy treatment for early-stage triple-negative breast cancer is enjoying a boom period, though there are still unanswered questions, particularly around the optimal chemotherapy backbone and patient selection.
ctDNA Assays Open the Door for Earlier Detection, Intervention in Breast Cancer
March 4th 2022Pat W. Whitworth, MD, explains how data from past studies are informing the use of circulating tumor DNA and talks about the potential of these assays to guide treatment decisions in patients with breast cancer.
Real-World Data Describe Eribulin Efficacy After Novel Agents for MBC
March 4th 2022Treatment with eribulin elicited an estimated 2-year overall survival rate of 53.6% for patients with metastatic breast cancer previously treated with atezolizumab or sacituzumab govitecan, according to real-world findings.
FDA Extends PDUFA Date for BLA/sNDA of Ublituximab Plus Umbralisib in CLL/SLL
March 3rd 2022The FDA has extended the Prescription Drug User Fee Act goal date for the biologics license application and supplemental new drug application seeking the approval of ublituximab plus umbralisib in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
NCCN Recommends Ropeginterferon Alfa-2b in Clinical Practice Guidelines Update
March 3rd 2022The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology have been revised to include ropeginterferon alfa-2b as a recommended treatment option for adult patients with polycythemia vera.
FDA Grants Fast Track Status to HPN217 for Relapsed/Refractory Multiple Myeloma
March 3rd 2022The FDA has granted a to the BCMA-targeting Tri-specific T-cell Activating Construct, HPN217, for use as a potential therapeutic option in patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy.