From IV to Oral: Leveraging Softgel to Extend Vinorelbine’s Lifecycle & Improve Patient Convenience
Summary: Vinorelbine, a chemotherapy agent traditionally given by IV infusion, was reformulated into the first approved oral softgel capsule through a collaboration between Pierre Fabre and Catalent. This innovation improved patient convenience, enabled treatment at home, and sustained brand value despite the entry of intravenous generics. Using Catalent’s softgel technology and dedicated cytotoxic manufacturing expertise, the new oral vinorelbine achieved bioequivalent systemic exposure to the IV product, offering oncologists and patients a flexible oral/IV switch strategy. This case study highlights how oral oncology drug development with softgel can extend product lifecycles while enhancing patient outcomes.