FDA accepts two priority review sBLAs for Padcev

The US Food and Drug Administration has accepted two supplemental Biologics License Application (sBLA) submissions for Padcev (enfortumab vedotin-ejfv) for review as part of the Real-Time Oncology Review (RTOR) pilot program.

Submitted by Japanese pharma Astellas Pharma (TYO: 4503) and US firm Seagen (Nasdaq: SGEN), the applications were granted Priority Review, with a target action date of August 17, 2021. The review of both applications will also be conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

The FDA’s RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. Project Orbis provides a framework for concurrent submission and review of oncology drugs among participating international partners.