How Rituxan Hycela became the first drug with patient preference data on its U.S. label
Rituxan Hycela subcutaneous rituximab provides the first example of how companies can get patient preference data on an FDA-approved drug label.
The new formulation is intended to reduce the treatment burden of rituximab therapy, which was previously available only as an IV infusion that took 1.5-6 hours. The subcutaneous formulation can be administered by a healthcare professional in 5-7 minutes.
In addition to pharmacokinetic bridging studies and head-to-head Phase III studies that showed no difference between the safety and efficacy of the two formulations, Roche conducted the Phase IIIb PrefMab study to generate data about patients’ experiences and preferences.
“Typically in a clinical trial, we collect a lot of safety and efficacy information. But rarely do we ask patients what it’s like to undergo treatment, how they experienced it and how it impacted their life,” Nancy Valente told BioCentury. Valente is VP of global product development in hematology and oncology at Roche’s Genentech Inc. unit.
“Rarely do we ask patients what it’s like to undergo treatment, how they experienced it and how it