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.
Cemiplimab Granted Positive EU Opinion for Advanced NSCLC and Basal Cell Carcinoma
May 24th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab for use in 2 advanced cancers: non–small cell lung cancer and basal cell carcinoma.
High TMB Fails to Show Predictive Biomarker Potential for Checkpoint Inhibition Across Cancers
May 24th 2021High tumor mutational burden was useful in predicting clinical responses to checkpoint inhibitors in patients with certain cancer subtypes; however, TMB-H failed to demonstrate utility as a biomarker for treatment with checkpoint inhibitors across all solid cancer types.
Nivolumab/Ipilimumab Approaches EU Approval for Post-Chemo dMMR or MSI-H Metastatic CRC
May 24th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of nivolumab and ipilimumab as an option for patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following fluoropyrimidine-based combination therapy.
FDA Extends Review Period for Narsoplimab for HSCT-TMA
May 21st 2021The FDA has announced that it will need more time to review the biologics license application for narsoplimab as a potential therapeutic option in patients with hematopoietic stem cell transplant–associated thrombotic microangiopathy.
FDA Grants Priority Review to Maribavir for Select Post-Transplant Recipients With CMV
May 21st 2021The FDA has accepted a new drug application for maribavir for the treatment of post-transplant recipients with cytomegalovirus infection who are refractory and/or resistant to previous anti-CMV treatment.
Radiation Strategies Blaze a Trail for Better Outcomes in CNS Cancers and Beyond
May 21st 2021Stephanie E. Weiss, MD, FASTRO and Eric M. Horwitz, MD, FABS, FASTRO, discuss ways to leverage radiation in the treatment of central nervous system metastases, areas of active investigation, and different available strategies that are improving outcomes for patients with cancer.
Frontline Tislelizumab Plus Chemo Improves PFS in Recurrent or Metastatic Nasopharyngeal Cancer
May 21st 2021The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.
Smoking Cessation Support Plays a Vital Role in Improving Lung Cancer Screening
May 21st 2021Results of the National Lung Screening Trial demonstrated a 20% decrease in lung cancer mortality in individuals aged 55 to 74 years with a 30 pack-year smoking history using a low-dose computed tomography scan.
Maintenance Rucaparib Shows Efficacy in Advanced Pancreatic Cancer Harboring BRCA1, BRCA2, or PALB2
May 20th 2021The PARP inhibitor rucaparib has proven to be a safe and effective maintenance option for patients with platinum-sensitive, advanced pancreatic cancer that harbors pathogenic variants such as BRCA1, BRCA2, or PALB2.
FDA Approves Adjuvant Nivolumab for Resected Esophageal or GEJ Cancer
May 20th 2021The FDA has approved nivolumab for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, in patients have received neoadjuvant chemoradiotherapy.
SBRT Appears to Be Safe, Feasible in Oligometastatic Disease With Multiple Metastases
May 20th 2021Stereotactic body radiotherapy can safely be used to treat patients with oligometastatic disease with 3 to 4 metastases or 2 metastases in close proximity to each other, according to results from the phase 1 NRG-BR001 trial.
Screening, Vaccination Guidance May Be Responsible for Decline in HPV-Related Cervical Cancer
May 19th 2021Evidence from a population-based study on the incidence of human papillomavirus–related cancers indicate a marked decline in cervical carcinoma, potentially due to clear guidance regarding screening measures and HPV vaccination for vulnerable patient groups.