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.
ADCs Represent One of Many Improvements in GU Cancer Treatment
November 28th 2022Daniel J. George, MD, discusses the impact that ADCs have had on the evolving treatment landscape of bladder cancer, long-term outcomes with immunotherapy in metastatic renal cell carcinoma, and highlighted current and ongoing research at the Duke Cancer Institute.
Perspectives From the Frontline: What Is Happening on the Ground With NGS Testing in NSCLC?
November 28th 2022Benjamin P. Levy, MD; Bhuvana Ramkumar, MD; and Neil Morganstein, MD, discuss the challenges with tissue testing facing care teams, as well as multilevel hurdles in procurement, analysis of results, and insurance.
PDS0101 Plus Chemoradiation Elicits 100% ORR in High-Risk Locally Advanced Cervical Cancer
November 23rd 2022PDS0101 given in conjunction with chemoradiation elicited an 100% overall response rate, along with tumor shrinkage greater than 60%, in 9 patients with high-risk, locally advanced cervical cancer, according to results of the phase 2 IMMUNOCERV trial.
Selpercatinib Approval in RET Fusion+ Solid Tumors Expands Tumor-Agnostic Feasibility
November 23rd 2022Alexander Drilon, MD, discusses key efficacy and safety data for selpercatinib from LIBRETTO-001, how the FDA approval of selpercatinib affects the current treatment landscape for RET fusion–positive advanced solid tumors, and ongoing research to expand the reach of tumor-agnostic drugs.
FGFR2 Inhibitor RLY-4008 Appears Durable, Tolerable in Cholangiocarcinoma
November 23rd 2022Suneel Kamath, MD, discusses the current challenges of treating patients with cholangiocarcinoma, the need for more tolerable therapies in this population, and how the significant ORRs and impressive safety profile seen so far with RLY-4008 in the ReFocus trial are indicative of this agent’s efficacy and durability in FGFR2-rearranged cholangiocarcinoma.
Dana-Farber Research Supports FDA Approval of New Therapy for Certain Patients With Ovarian Cancer
November 23rd 2022Mirvetuximab soravtansine has been granted accelerated approval by the U.S. Food and Drug Administration on November 14 for the treatment of recurrent platinum-resistant high-grade serous ovarian cancer that highly expresses folate receptor alpha.
FDA Extends PDUFA Date for BLA of Omidubicel in Blood Cancers Requiring Transplant
November 23rd 2022The FDA has extended the Prescription Drug User Fee Act goal date to May 1, 2023, for the biologics license application seeking the approval of omidubicel for patients with blood cancers in need of allogenic hematopoietic stem cell transplant.
DetermaIO Assay Helps Inform Benefit With Single-Agent Immunotherapy in Advanced NSCLC
November 22nd 2022The score of the 27-gene Determa immune-oncology assay demonstrated a correlation with overall survival and progression-free survival in patients with advanced non–small cell lung cancer treated with single-agent immunotherapy, regardless of performance status.
Sylvester Scientists Discover a New Therapeutic Target to Treat Deadly Breast Cancer
November 22nd 2022Researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine have shown that a protein complex that governs gene expression sometimes gets rewired during breast cancer to help estrogen receptor positive tumors resist endocrine therapies and become more aggressive.
Belantamab Mafodotin to Be Withdrawn From US Market for Relapsed/Refractory Myeloma
November 22nd 2022GlaxoSmithKline plc has initiated the process to withdraw the United States marketing authorization for belantamab mafodotin-blmf for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies.
European Commission Approves Cemiplimab for Recurrent or Metastatic Cervical Cancer
November 22nd 2022The European Commission has approved cemiplimab-rwlc monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy.