EP. 1: FDA Grants Priority Review to Sunvozertinib in EGFR+ NSCLC
The FDA granted priority review to sunvozertinib for the treatment of advanced NSCLC with EGFR exon 20 mutations, based on promising efficacy and safety data from the WU-KONG1 trial.
EP. 2: FDA Fast Tracks Abenacianine for Lung Cancer Surgery
Abenacianine, a tumor-targeted fluorescent imaging agent, received fast track designation from the FDA after demonstrating its safety and efficacy in visualizing lung tumors in a phase 2 study.
EP. 3: FDA Grants B7-H3–Targeted ADC Breakthrough Status in Osteosarcoma
The FDA’s breakthrough therapy designation for GSK’227 underscores its potential to address the critical unmet needs of patients with relapsed/refractory osteosarcoma.
EP. 4: FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications.
EP. 5: Amezalpat Gains FDA Orphan Drug Status in HCC
The FDA granted orphan drug designation to amezalpat in hepatocellular carcinoma based on phase 1b/2 data showing efficacy and safety with atezolizumab and bevacizumab in frontline treatment.
