Expedited pathway portfolios, trial complexity, and FDA approval…
FDA expedited programs are intended to facilitate development and review for therapies addressing serious conditions with unmet medical need, but their use may depend on whether the evidentiary package is compatible with regulatory acceleration. We compared FDA original approvals in oncology and neurology from 2015 to 2024 to evaluate whether differences in approval timing reflected expedited pathway portfolio intensity, pivotal evidence architecture, or alignment between the two.
- Lab
- Preclinical
- Early trials
- Late trials
- In practice
A Phase 1 First-Time-in-Human, Open-Label Study of Nelistotug…
This first-in-human, nonrandomized, multicenter study investigated nelistotug (anti-CD96 monoclonal antibody [mAb]) as monotherapy (Arm A) and in combination with dostarlimab (anti-PD-1 mAb) (Arm B), and dostarlimab plus belrestotug (anti-TIGIT mAb) (Arm F) in patients with recurrent or advanced solid tumors. Patients received intravenous doses every 3 weeks of nelistotug 2.
Novel or significantly improved treatmentAdvances and future perspectives in the treatment of small cell lung cancer
Small cell lung cancer (SCLC) is an aggressive malignant tumor that mainly originates from pulmonary neuroendocrine cells and is characterized by rapid proliferation, high metastatic potential, and acquired therapeutic resistance. The therapeutic landscape for SCLC is largely confined to traditional modalities, such as surgery and chemoradiotherapy.
Promising but preliminaryAnomaly Detection With an Expanded Standardized First-Trimester Fetal…
To evaluate the clinical utility of a novel comprehensive StaFFAUS (standardized first-trimester fetal anatomic ultrasound screening) protocol. This retrospective single-center study included pregnant patients undergoing first-trimester ultrasound screening at 11 6/7-13 6/7 weeks of gestation between 2013 and 2024.
Early cancer detection or preventionOsimertinib plus anlotinib in untreated, EGFR-mutated, advanced…
The standard first-line treatment for advanced EGFR-mutated non-small cell lung cancer (NSCLC) is EGFR tyrosine kinase inhibitors. However, concurrent mutations facilitate resistance evolution in EGFR-mutant lung adenocarcinoma and combination therapies may offer a superior approach.