Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny
AstraZeneca's Imfinzi (durvalumab) received FDA approval for use in combination with FLOT chemotherapy for perioperative treatment of resectable early gastric and gastroesophageal junction (GEJ) cancers.
This is the first and only immunotherapy regimen approved in the neoadjuvant setting for these cancers, based on the MATTERHORN Phase III trial showing improved event-free and overall survival.
The approval marks the third US perioperative indication for Imfinzi, expanding its use in early-stage cancers.
BiomX's BX004 program faces an FDA clinical hold due to concerns about the third-party nebulizer device used for delivery; the company has submitted requested safety data and believes it has addressed the FDA's queries.
Regulatory applications for Imfinzi in this indication are under review in the EU, Japan, Canada, and other countries as part of Project Orbis.