Jordyn Sava is an editor for Targeted Oncology.
FDA Accepts BLA for N-803 in BCG-Unresponsive NMIBC Carcinoma In Situ
July 29th 2022The FDA has accepted the biologics license application for N-803 as a treatment for patients with Bacillus Calmette–Guérin-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
Weekly Dose-Dense Paclitaxel Not Recommended as Standard Therapy for 1L Ovarian Cancer
July 29th 2022Mature survival data from the phase 3 ICON8 trial revealed no significant difference between administering weekly dose-dense chemotherapy and standard 3-weekly chemotherapy as front-line therapy for patients with epithelial ovarian cancer.
CDK4/6 Inhibitors are Beneficial in HR+ MBC Harboring ESR1 Mutations and Fusions
July 29th 2022In an interview with Targeted Oncology, Jamie Brett and Seth Wander, MD, PhD, discussed recent findings regarding CDK4/6 for patients with hormone receptor-positive metastatic breast cancer with ESR1 alterations.
Phase 2 INSPIRE Trial of IRX-2 Misses EFS End Point in Head and Neck Cancer
July 28th 2022IRX-2 did not demonstrate a statistically significant improvement in event-free survival as neoadjuvant therapy vs standard of care in patients with newly diagnosed, stage II, III, or IVA squamous cell carcinoma of the oral cavity, according to data from the phase 2 INSPIRE trial.
Increased Hemithyroidectomy Use in Thyroid Cancer Not Linked With ATA Guidelines
July 25th 2022Focused cancer centers increased hemithyroidectomy 2 years prior to the release of the newest American Thyroid Association guidelines. However, only community cancer program hospitals began to increase hemithyroidectomy utilization following release of guidelines.
Early Efficacy Shown With Gemcitabine/Cabazitaxel/Pembrolizumab in NMIUC
July 24th 2022In an interview with Targeted Oncology, Vignesh Packiam, MD, discussed the research of gemcitabine plus cabazitaxel and pembrolizumab in patients with non-muscle invasive urothelial carcinoma who are unresponsive to docetaxel.
Trials Lead to Change in Prescription Patterns for Older Adults With Colorectal Cancer
July 22nd 2022The phase 3 CALGB 9343 study significantly changed prescription patterns for patients with metastatic colorectal cancer, according to a presentation at the International Society for Pharmacoeconomics and Outcomes Research 2022.
Asciminib Improves Efficacy vs Other Third-Line Treatments in Chronic Phase CML
July 22nd 2022Data revealed that a longer time to treatment discontinuation seen with asciminib favored its relative tolerability, correlating with the better-observed safety profile, according to data presented at the International Society for Pharmacoeconomics and Outcomes Research 2022
FDA Grants Fast Track and Rare Pediatric Disease Designations for WU-CART-007 in T-ALL/LBL
July 20th 2022The FDA has granted fast track designation and rare pediatric disease designation for WU-CART-007 as treatment for patients with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma.
Higher Residual Cancer Burden Score Linked to Worse Event-Free Survival in TNBC
July 18th 2022In an interview with Targeted Oncology, Lajos Pusztai, MD, DPhil, discussed the updated findings of the phase 3 KEYNOTE-522 clinical trial of pembrolizumab plus chemotherapy in patients with TNBC vs placebo plus chemotherapy.
FDA’s ODAC Discusses Framework for Decision-Making in Pediatric Assessments
July 18th 2022The Pediatric Oncology Subcommittee of the FDA’s Oncologic Drug Advisory Committee met to discuss the assessment of new drugs for the treatment of pediatric cancers. The goal of the meeting was to develop a new framework for application review.
Pertuzumab-Based Regimen Shows Continued Benefit in HER2-Positive Breast Cancer
July 15th 2022Findings from the phase 3 APHINITY study show that the combination pertuzumab, trastuzumab, and chemotherapy improves invasive disease-free survival compared with trastuzumab and chemotherapy alone in patients with lymph node-positive, HER2-positive early breast cancer.
Sabizabulin Deemed Safe in Metastatic Castration-Resistant Prostate Cancer
July 14th 2022In the interview, Mark Markowski, MD, discussed how the findings from the phase 1/2 trial of sabizabulin in patients with metastatic castration-resistant prostate cancer this may influence future research with the oral agent.
FDA Grants Orphan Drug and Fast Track Designations to Sonodynamic Therapy in Brain Cancers
July 13th 2022An orphan drug designation and a fast track designation have been granted by the FDA to a novel sonodynamic therapy platform as a potential treatment for patients with recurrent glioblastoma and other malignant gliomas.