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.

Erdafitinib Approaches EU Approval for FGFR3+ Unresectable or Metastatic Urothelial Carcinoma

June 28th 2024

The EMA's CHMP has adopted a positive opinion regarding erdafitinib in patients with FGFR3+ unresectable or metastatic urothelial carcinoma.

CHMP Recommends Odronextamab for Relapsed/Refractory FL and DLBCL

June 28th 2024

The EMA's CHMP has recommended the conditional marketing authorization of odronextamab for relapsed/refractory FL and DLBCL.

FDA Approves Tepylute for Breast and Ovarian Cancer Treatment

June 28th 2024

The FDA has approved a new drug application for Tepylute, a ready-to-dilute formulation to treat breast and ovarian cancers.

Do Tumor-Naive MRD Assays Have a Role in Resected CRC? Cremolini Weighs in

June 28th 2024

Chiara Cremolini, MD, discusses the role of ctDNA in assessing minimal residual disease in patients with CRC.

huCART19-IL18 Is Tolerable, Induces Responses in CAR T-Cell–Pretreated R/R Lymphoma

June 27th 2024

Armored huCART19-IL18 treatment was tolerable in patients with relapsed/refractory lymphomas who progressed after CD19-directed CAR T-cell therapy.

Lunresertib Plus FOLFIRI Shows Safety, Elicits Responses in CCNE1+ or FBXW7+ Advanced GI Tumors

June 27th 2024

Lunresertib plus FOLFIRI was safe and produced responses in advanced gastrointestinal tumors harboring CCNE1 amplifications or FBXW7 alterations.

Adding Celecoxib to Adjuvant Chemotherapy Offers DFS, OS Benefit in PIK3CA-Mutated Stage III Colon Cancer

June 27th 2024

Celecoxib plus adjuvant chemotherapy led to extended DFS and OS vs placebo plus adjuvant chemotherapy in PIK3CA-mutated stage III colon cancer.

Breaking New Ground in Biological Therapies for Cancer

June 27th 2024

The financial performance of Florida Cancer Specialists & Research Institute for the first two months of 2024 surpassed the statewide practice’s budget.

Ficerafusp Alfa/Pembrolizumab Demonstrates Clinically Meaningful Activity in Metastatic HNSCC

June 27th 2024

The bifunctional antibody ficerafusp alfa plus pembrolizumab generated clinically meaningful activity in HPV–recurrent/metastatic HNSCC.

MPO Could Represent Predictive OS Biomarker for CM24 Plus Nivolumab/Chemo in Second-Line PDAC

June 27th 2024

MPO may be a predictive biomarker for survival for treatment with CM24, nivolumab, and chemotherapy in second-line pancreatic ductal adenocarcinoma.

FDA Modifies REMS for Autologous CAR T-Cell Therapies in Hematologic Malignancies

June 27th 2024

The FDA has modified the risk evaluation and mitigation strategies for CAR T-cell therapies approved for hematologic malignancies.

Lutetium Lu 177 Dotatate Enters the Pediatric Treatment Paradigm for SSTR+ GEP-NETs

June 27th 2024

Daniel M. Halperin, MD, details the FDA approval of lutetium Lu 177 dotatate as well as safety and efficacy data in pediatric and adult patients treated with the agent.

FDA Issues CRL for Patritumab Deruxtecan in Pretreated EGFR+ NSCLC

June 27th 2024

The FDA has issued a complete response letter to the BLA for patritumab deruxtecan in pretreated advanced EGFR-mutated non–small cell lung cancer.

Liso-cel Shows Improved EFS, PFS, and Durable Responses in Second-line LBCL at 3 Years

June 27th 2024

Liso-cel continued to show improved disease control and EFS and PFS vs SOC in the second-line treatment of patients with large B-cell lymphoma.

FDA Grants Accelerated Approval to Epcoritamab for Relapsed/Refractory Follicular Lymphoma

June 26th 2024

The FDA has granted accelerated approval to epcoritamab-bysp (Epkinly) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

Lutetium Lu 177 Dotatate Maintains PFS, ORR Benefits Across Subgroups in SSTR+ GEP-NETs

June 26th 2024

Lutetium Lu 177 dotatate with octreotide led to a clinical benefit in PFS and ORR regardless of tumor grade or primary origin in advanced grade 2 and grade 3 GEP-NETs.

Cetuximab Biosimilar Receives NMPA Approval For RAS/BRAF Wild-Type CRC

June 26th 2024

First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.

Intrathecal Dendritic Cells Under Evaluation for Leptomeningeal Disease in TNBC and HER2+ Breast Cancer

June 26th 2024

Peter Forsyth, MD, on the investigation of intrathecal dendritic cells for leptomeningeal disease in triple-negative and HER2-positive breast cancer.

Mitazalimab Plus mFOLFIRINOX Yields 18-Month OS Benefit in Previously Untreated Metastatic Pancreatic Cancer

June 26th 2024

Frontline mitazalimab plus mFOLFIRINOX generated an OS benefit and prolonged DOR in patients with metastatic pancreatic ductal adenocarcinoma.

China’s NMPA Approves First-Line Osimertinib Plus Chemotherapy in EGFR-Mutant NSCLC

June 26th 2024

Osimertinib received approval in China in combination with pemetrexed and platinum-based chemotherapy for patients with advanced EGFR-mutant NSCLC.