Overview
- Approval covers adult patients whose disease relapsed or was refractory after two or more prior systemic therapies.
- In the phase 1/2 GO29781 study, the subcutaneous regimen achieved a 75% overall response rate and a 59% complete response rate, with a median duration of response of 22.4 months.
- Primary analysis also showed a median progression-free survival of 23.7 months, while overall survival was not reached at the time of reporting.
- Safety findings included any-grade adverse events in about 99% of patients and cytokine release syndrome in roughly 30%, typically low grade and resolving after a median of two days.
- The injection can be given in about one minute and follows a fixed-duration outpatient schedule that may be completed in as little as six months, and the U.S. action follows a November conditional authorization in the EU with confirmatory trials required for full approval.