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.

GI Cancer Research Lends Insight Into the Future of Chemotherapy Combinations and Sequencing

July 24th 2023

Mark Lewis, MD, discusses the contested designs of the NorPACT-1 trial and NAPOLI 3 trial; where trastuzumab deruxtecan falls in the HER2-positive metastatic colorectal cancer treatment paradigm; and how the PROSPECT trial results can improve quality of life for patients with rectal cancer.

Arend Named New Co-Leader of Experimental Therapeutics Program

July 24th 2023

The O’Neal Comprehensive Cancer Center at UAB is pleased to announce that Rebecca Arend, M.D., MSPH, will join Drs. Narendra Wajapeyee and Suzanne Lapi as Co-Leader of the O’Neal Experimental Therapeutics Research Program.

Loncastuximab Tesirine BLA Receives Priority Review in China for Relapsed/Refractory DLBCL

July 24th 2023

The China National Medical Products Administration has accepted and granted priority review to the biologics license application seeking the approval of loncastuximab tesirine-lpyl for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma following at least 2 prior lines of systemic therapy.

Axatilimab Meets ORR End Point in Chronic GVHD After 2 or More Prior Lines of Therapy

July 24th 2023

The anti–CSF-R1 antibody axatilimab generated responses in adult and pediatric patients with chronic graft-vs-host disease who received 2 or more prior lines of therapy, meeting the primary end point in all cohorts of patients in the phase 2 AGAVE-201 trial.

FDA Approves Companion Diagnostic for Quizartinib in FLT3-ITD+ AML

July 24th 2023

The FDA has approved the LeukoStrat CDx FLT3 Mutation Assay for use as a companion diagnostic to select patients with FLT3-ITD–positive acute myeloid leukemia who may be eligible to receive treatment with quizartinib (Vanflyta).1

CHMP Advises Against Adagrasib Approval for KRAS G12C–Mutant Advanced NSCLC

July 24th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.

Evaluating Toxicities of Antineoplastic Drug Therapeutics: Is It Time for a Critical Review?

July 24th 2023

An evaluation of the utility of a cancer therapeutic in a clinical trial is determined through metrics that define 2 distinctive features of an antineoplastic strategy: efficacy and toxicity. Although that may be an oversimplification, the aim of such therapy is to improve clinical outcomes.

Fianlimab Plus Cemiplimab Produces Durable Responses in Advanced Melanoma

July 24th 2023

Omid Hamid, MD, discusses the key efficacy and safety findings for the combination of fianlimab plus cemiplimab in patients with advanced melanoma.

Regional Nodal Irradiation Has Minimal Effect on Locoregional Recurrence in Favorable-Risk, Node-Positive Breast Cancer

July 23rd 2023

Locoregional recurrence rates among patients with favorable-risk, node-positive hormone receptor-positive, HER2-negative breast cancer was not significantly reduced by the addition of regional nodal irradiation to these patient’s treatment regimens.

Surgery and Radiotherapy Generate Similar Long-Term PROs in OPSCC

July 22nd 2023

Long-term assessments did not reveal differences in patient-reported outcomes between primary surgery or radiotherapy for patients with oropharyngeal squamous cell carcinoma.

JZP458 Receives CHMP Recommendation for Approval in ALL, Lymphoblastic Lymphoma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.

Teclistamab Snags Positive CHMP Opinion for Relapsed/Refractory Multiple Myeloma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.

CHMP Recommends Talquetamab Monotherapy for R/R Multiple Myeloma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.

ASCP’s Outstanding Education Initiatives Receive Prestigious Awards

July 21st 2023

Two innovative ASCP education initiatives have received accolades from the Alliance for Continuing Education in the Health Professions.

CHMP Supports Approval of Pembrolizumab Plus Trastuzumab/Chemotherapy for HER2+, PD-L1+ Advanced Gastric/GEJ Cancer

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors have a PD-L1 combined positive score of at least 1.

Adjuvant Nivolumab Receives CHMP Recommendation for Completely Resected Stage IIB/C Melanoma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.

Epcoritamab Approaches EU Approval for Relapsed/Refractory DLBCL

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending conditional marketing authorization to epcoritamab monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.

Older Patients Experience Functional Recovery 3 Months After Major Surgery for CRC

July 21st 2023

Three months following a major colorectal cancer surgery, the majority of older patients achieved functional recovery.

First-Line NALIRIFOX Demonstrates Survival Advantage Over Standard Gemcitabine/Paclitaxel in Metastatic PDAC

July 21st 2023

Eileen M. O’Reilly, MD, expands on the updated survival data from NAPOLI-3, explains how NALIRIFOX could fit into the current pancreatic ductal adenocarcinoma treatment paradigm, and shares potential opportunities to build upon this research moving forward.

FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML

July 20th 2023

The FDA has approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.