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.

Subcutaneous Atezolizumab Approved in Great Britain for All Intravenous Indications

August 29th 2023

Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.

FDA Grants Orphan Drug Designation to Bexmarilimab for AML

August 29th 2023

The FDA has granted an orphan drug designation to bexmarilimab for the treatment of patients with acute myeloid leukemia.

Gene Therapy Study Identifies Potential New Treatment for Liver Cancer

August 29th 2023

Gene therapy that induces the body to create microRNA-22, a naturally occurring molecule, successfully treated mice with hepatocellular carcinoma, the most common form of liver cancer.

FDA Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma

August 29th 2023

A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.

Pembrolizumab Plus Trastuzumab and Chemotherapy Receives European Approval in HER2+ Gastric/GEJ Cancer

August 29th 2023

The European Commission has approved pembrolizumab for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 1.

TROPiCS-02 Data Reinforce Role of Sacituzumab Govitecan as a SOC in HR+ Breast Cancer

August 29th 2023

Sara M. Tolaney, MD, MPH, highlights updated survival and safety data seen with sacituzumab govitecan in patients with hormone receptor–positive, HER2-negative breast cancer; underscores how Trop-2 and HER2 testing is not necessarily needed for this agent in this population at this time; and shares how ongoing efforts are exploring the utilization of this agent earlier in the treatment course.

Pembrolizumab With COPDAC-28 Consolidation Increases PET Negativity in Classical Hodgkin Lymphoma

August 29th 2023

The addition of pembrolizumab to COPDAC-28 consolidation may augment responses to treatment in pediatric and young adult patients with high-risk classical Hodgkin lymphoma who experience a slow early response to frontline chemotherapy.

FDA Approves Luspatercept for First-line Treatment of Anemia in Lower-Risk MDS

August 29th 2023

The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia without prior erythropoiesis stimulating agent (ESA) use in adult patients with very low– to intermediate-risk myelodysplastic syndrome (MDS) who may require regular red blood cell (RBC) transfusions.

Trastuzumab Deruxtecan May Represent Potential Option for HER2-Expressing Solid Tumors

August 28th 2023

Funda Meric-Bernstam, MD, discusses the design of the DESTINY-PanTumor02 trial, details the antitumor activity and safety of T-DXd in HER2-expressing solid tumors, and shares additional analyses that will be coming down the pike.

Bazhenova Details Potential Pathways Forward for Targeting KRAS Mutations in NSCLC

August 28th 2023

Lyudmila A. Bazhenova, MD, discusses upcoming inhibitors of interest in the combination therapy space for patients with KRAS G12C–mutant NSCLC.

Petrylak Provides Perspective on the Nationwide Cisplatin/Carboplatin Shortage

August 28th 2023

Daniel P. Petrylak, MD, discusses strategies he and his colleagues at Yale Cancer Center have employed to reduce the effect of the current chemotherapy shortage on patients, and emphasizes the need to reassess current manufacturing strategies in an effort to potentially mitigate future drug shortages.

Radical Cystectomy or Bladder Preservation: Understanding Optimal Therapy for Locally Advanced Bladder Cancer

August 28th 2023

Neil Desai, MD, MHS, expands on the need for further research regarding potential treatment strategies for patients with locally advanced, nonmetastatic muscle-invasive bladder cancer who may not benefit from standard approaches.

Estrogen Receptor Mutation Study Suggests Potential Treatments For Endometrial Cancers

August 28th 2023

Researchers at Huntsman Cancer Institute identified potential new treatment options for people with endometrial cancer.

TTFields Plus Paclitaxel Misses OS End Point in Platinum-Resistant Ovarian Cancer

August 28th 2023

The addition of tumor treating fields to paclitaxel did not result in a statistically significant improvement in overall survival vs paclitaxel alone in patients with platinum-resistant ovarian cancer, failing to meet the primary end point of the phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 trial.

Komrokji Examines Differences Between the WHO and ICC MDS Criteria

August 28th 2023

Rami Komrokji, MD, discusses an international dataset analysis of the 2 current classification systems for patients with myelodysplastic syndromes, as well as the next steps being taken to develop a more harmonized classification system.

Subcutaneous Trastuzumab Proves Safe and Tolerable in HER2+ Metastatic Breast Cancer

August 28th 2023

The safety profile of subcutaneous trastuzumab was consistent with the known profile of intravenous administration of the agent and there were no new concerns related to prolonged exposure in patients with HER2-positive metastatic breast cancer.

Niraparib Maintenance Extends PFS in Newly Diagnosed Ovarian Cancer

August 27th 2023

Maintenance therapy with the PARP inhibitor niraparib prolonged progression-free survival vs placebo in patients with newly diagnosed advanced ovarian cancer.

Postoperative ctDNA Provides Prognostic Value for DFS Outcomes in CRC

August 26th 2023

Circulating tumor DNA status at the time of postoperative minimal residual disease assessment was found to be a prognostic factor for disease-free survival in patients with radically resected stage II to IV colorectal cancer.

European Medicines Agency Grants Orphan Drug Designation to Mitazalimab for Pancreatic Cancer

August 25th 2023

The European Medicines Agency has granted orphan drug designation to mitazalimab for use in patients with pancreatic cancer.

Rural Patient Populations at Higher Risk of Lung Cancer Mortality

August 25th 2023

Logan Roof, MD, discusses the importance of investigating demographic disparities that exist in lung cancer mortality, expands on the results of the population-based CDC database analysis, and discusses potential next steps to address these disparities in the future.