All Oncology News

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.

Berubicin Demonstrates Early Promise in Recurrent or Refractory Glioblastoma Multiforme

August 15th 2023

Berubicin was found to have acceptable tolerability when administered as second-line treatment in patients with recurrent or refractory glioblastoma multiforme.

FDA Approves HEPZATO KIT for Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

August 15th 2023

The FDA has approved HEPZATO KIT (melphalan/Hepatic Delivery System) for use in the treatment of select patients with unresectable hepatic-dominant metastatic uveal melanoma.

FDA Approves Companion Diagnostic for Niraparib Plus Abiraterone Acetate in BRCA+ mCRPC

August 14th 2023

The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

FDA Places Clinical Hold on Phase 1 Trial of SC-DARIC33 in Pediatric R/R CD33+ AML

August 14th 2023

The FDA has placed a clinical hold on the phase 1 PLAT-08 trial evaluating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia.

Molecular Subtyping and Surgical Sequencing Broaden Immunotherapy Applications in RCC

August 14th 2023

Tian Zhang, MD, discusses unanswered questions regarding molecular drivers of kidney cancer that the OPTIC RCC trial aims to answer, next steps with this research, and the potential benefits of receiving systemic therapy prior to undergoing cytoreductive nephrectomy for patients with metastatic renal cell carcinoma.

FDA Approves Elranatamab for Relapsed or Refractory Multiple Myeloma

August 14th 2023

The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Hackensack Meridian JFK University Medical Center Thoracic Surgeons Perform the First Robotic Resection Surgery for Malignant Thymoma with Intraoperative Installation of Heated Chemotherapy

August 14th 2023

Surgeons affiliated with Hackensack Meridian JFK University Medical Center’s Advanced Lung and Airway Center successfully performed the first robotic resection of malignant thymoma, a cancer of the thymus gland, followed by installation of heated chemotherapy into the chest.

FDA Grants Orphan Drug Designation to Quratusugene Ozeplasmid for Small Cell Lung Cancer

August 14th 2023

The FDA has granted an orphan drug designation to quratusugene ozeplasmid (Reqorsa) for the treatment of patients with small cell lung cancer.

BAT8006 Elicits Disease Control, Safety in Advanced Ovarian Cancer and Other Solid Tumors

August 14th 2023

Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.

Unresolved Issues in Antineoplastic Drug Therapy: Is It Finally Time to Address?

August 14th 2023

Several articles featured in a recent issue of the highly respected publication the Medical Letter on Drugs and Therapeutics highlight themes across drug development that are relevant within the broad antineoplastic arena. The topics range from appropriate control arms in randomized clinical trials to sponsorship of trials to the rationale for developing novel agents when suitable, cost-effective biosimilar and generic products are available.

GVAX Cancer Vaccine Plus Nivolumab and Urelumab Elicits Early Efficacy in Pancreatic Adenocarcinoma

August 14th 2023

Treatment with the GVAX pancreatic cancer vaccine plus nivolumab and urelumab increased the presence of intratumoral activated cytotoxic T cells and showed early signs of efficacy in patients with resectable pancreatic adenocarcinoma.

IBI322 Shows Early Antitumor Efficacy in PD-1/PD-L1–Resistant Classical Hodgkin Lymphoma

August 13th 2023

Single-agent IBI322 elicited responses with favorable safety in patients with classical Hodgkin lymphoma that had become resistant to anti–PD-1/PD-L1 therapy, according to data from a phase 1 trial.

Extended Treatment With CAEL-101 Plus SOC Therapy Proves Safe in Light-Chain Amyloidosis

August 12th 2023

The addition of the chimeric monoclonal antibody CAEL-101 to standard therapy with cyclophosphamide, bortezomib, and dexamethasone with or without daratumumab demonstrated a manageable toxicity profile with prolonged clinical benefit in patients with amyloid light-chain amyloidosis.

FDA Approves Niraparib Plus Abiraterone Acetate for BRCA+ mCRPC

August 11th 2023

The FDA has approved niraparib plus abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive, metastatic castration-resistant prostate cancer, as detected by an FDA-approved test.

Cancer Vaccine IFx-Hu2.0 Confers Immune Priming Effect in Previously Treated MCC and CSCC

August 11th 2023

The novel personalized cancer vaccine IFx-Hu2.0 was found to be safe and well tolerated with weekly dosing in patients with checkpoint inhibitor–resistant cutaneous squamous cell carcinoma and Merkel cell carcinoma, according to data from an ongoing phase 1b trial.

Teclistamab Plus Nirogacestat Elicits Durable Responses in Relapsed/Refractory Myeloma

August 11th 2023

The combination of teclistamab and nirogacestat produced high and deep responses in patients with relapsed/refractory multiple myeloma.

Early Efficacy of BL-B01D1 in a Phase 1 Study Reflects Potential for ADCs in Lung Cancer and Beyond

August 11th 2023

Helena A. Yu, MD, discusses the investigation of BL-B01D1 in patients with advanced solid tumors, the potential significance of this research for those with EGFR-mutant and wild-type disease, and the expanding body of evidence supporting continued antibody-drug conjugate development in non–small cell lung cancer.

Tirabrutinib Generates Sustained Efficacy in Relapsed/Refractory PCNSL

August 11th 2023

Treatment with the second-generation BTK inhibitor tirabrutinib continued to elicit durable responses in patients with relapsed/refractory primary central nervous system lymphoma, according to findings from the final 3-year analysis of a phase 1/2 trial.

Ofranergene Obadenovec Plus Paclitaxel Misses the Mark in Platinum-Resistant Ovarian Cancer

August 11th 2023

The addition of ofranergene obadenovec to paclitaxel failed to significantly improve survival outcomes compared with paclitaxel alone in patients with platinum-resistant ovarian cancer.

FCS Co-authored Study Confirms Effectiveness of Trilaciclib for Treatment of Patients with Extensive-Stage Small Cell Lung Cancer

August 11th 2023

Florida Cancer Specialists & Research Institute, LLC, physicians and senior leaders are co-authors of a study that confirms the effectiveness of trilaciclib for the treatment of adult patients with extensive-stage small cell lung cancer.