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.

NT219 Plus Cetuximab Elicits Responses, Demonstrates Tolerability in Recurrent or Metastatic HNSCC

October 3rd 2023

Second-line treatment with NT219 alone and in combination with cetuximab demonstrated safety and tolerability, and the combination produced confirmed partial responses in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

EMA Validates MAA for Imetelstat for Transfusion-Dependent Anemia in Lower-Risk MDS

October 3rd 2023

The European Medicines Agency has validated the marketing authorization application for the use of imetelstat in the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.

Multiple Myeloma Call-to-Action Plan Seeks to Ignite Widespread, Patient-Focused Change

October 3rd 2023

Faith E. Davies, MD, discusses the overarching goals of the Multiple Myeloma Call-to-Action, unmet needs that this plan seeks to alleviate, and ways in which all medical professionals could adopt these tenets into their practice to achieve global change in the care of patients with multiple myeloma.

Evorpacept Plus Trastuzumab/Ramucirumab/Paclitaxel Improves ORR in Pretreated, Advanced HER2+ Gastric/GEJ Cancer

October 3rd 2023

Second- or third-line treatment with the CD47 blocker evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel improved responses vs trastuzumab/ramucirumab/paclitaxel alone in patients with HER2-positive, advanced gastric and gastroesophageal junction cancer.

New California Tobacco Cessation Policy Research Center to be Housed at Cancer Center

October 3rd 2023

UC Davis Comprehensive Cancer Center has launched the state’s first-ever Tobacco Cessation Policy Research Center.

FDA Grants Fast Track Designation to BI 764532 for ES-SCLC and Extrapulmonary NEC

October 3rd 2023

The FDA has granted a fast track designation to BI 764532 for the treatment of patients with extensive-stage small cell lung cancer that has progressed following at least 2 prior lines of treatment, and for patients with advanced or metastatic extrapulmonary neuroendocrine carcinoma that has progressed following at least 1 prior line of treatment.

PDS0101 Plus Pembrolizumab Elicits 74% 2-Year OS Rate in ICI-Naïve, HPV16+ HNSCC

October 3rd 2023

The addition of PDS0101 to pembrolizumab resulted in a 2-year overall survival rate of 74% in patients with unresectable, recurrent, or metastatic, HPV16-positive head and neck squamous cell carcinoma who were naïve to an immune checkpoint inhibitor.

Takeda to Voluntarily Withdraw Mobocertinib for EGFR Exon 20 Insertion+ NSCLC

October 2nd 2023

Takeda has announced plans to voluntarily withdraw mobocertinib in the United States for adult patients with EGFR exon 20 insertion mutation–positive, locally advanced or metastatic non–small cell lung cancer whose disease has progressed on or following platinum-based chemotherapy.

FDA Grants Marketing Authorization to First DNA Test to Assess Genetic Predisposition to Select Cancers

October 2nd 2023

The FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test designed to detect genetic variants associated with an elevated risk of developing certain types of cancer.

Hypofractionated and Conventionally Fractionated Radiotherapy Generate Similar QOL, Safety in Breast Cancer

October 2nd 2023

Patients with breast cancer who received hypofractionated postmastectomy radiotherapy experienced similar toxicities vs those who received conventionally fractionated postmastectomy radiotherapy, according to a presentation shared at the 2023 American Society for Radiation Oncology Annual Meeting.

Japanese Approval Sought for Fruquintinib in Previously Treated Metastatic Colorectal Cancer

October 2nd 2023

A 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 2023

The 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.

FDA Grants Orphan Drug Designation to BDC-1001 in Gastric Cancers

October 2nd 2023

The FDA has given an orphan drug designation to BDC-1001 for the treatment of patients with gastric cancers, including gastroesophageal junction cancer.

Revumenib Meets CR/CRh End Point in KMT2A-Rearranged Relapsed/Refractory AML/ALL

October 2nd 2023

Treatment 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.

Ontada Names Christine Davis Its New President

October 2nd 2023

Ontada, a McKesson business dedicated to leveraging oncology real-world data and evidence, clinical education, and provider technology, announced the appointment of Christine Davis as its new president.

FDA Approves On-Body Injector for Self Administration of Pegcetacoplan for PNH

October 2nd 2023

The FDA has approved the Empaveli Injector designed to enhance the self administration of pegcetacoplan, which is approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.

FDA Awards Orphan Drug Designation to Alisertib in ES-SCLC

October 1st 2023

The FDA has granted an orphan drug designation to alisertib (MLN8237) for the treatment of patients with extensive-stage small cell lung cancer.

Venetoclax/Carfilzomib/Dexamethasone Triplet Shows Early Efficacy in t(11;14)+ R/R Myeloma

September 30th 2023

The 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.

NXC-201 Demonstrates Feasibility of BCMA-Directed CAR T-Cell Therapy in Relapsed/Refractory AL Amyloidosis

September 30th 2023

The novel anti-BCMA CAR T-cell therapy NXC-201 displayed safety and elicited hematologic and organ responses in patients with relapsed/refractory amyloid light chain amyloidosis, including frail patients.

Cilta-Cel Leads to High PFS Rates in Patients With Multiple Myeloma and Poor Prognostic Features

September 30th 2023

Patients 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.