BESPONSA can cause liver problems that can be severe, life-threatening, or fatal, including a condition called veno-occlusive disease (VOD). This condition can occur during treatment with BESPONSA or following subsequent treatment with a stem cell transplant. This condition was more common in patients who had elevated liver tests or who received dual alkylating agents in preparation for their stem cell transplant. Patients may be at a higher risk of VOD if they: . The Food and Drug Administration approved BESPONSA based on the results of the clinical trial that showed treatment with BESPONSA compared to chemotherapy improved complete remission (CR) rates (36% vs 17%), length of CR (8.0 months vs 4.9 months), and minimal residual disease–negative CR rates (90% vs 32%).. BESPONSA was evaluated versus chemotherapy in a large, global clinical trial in 326 adults with relapsed or refractory ALL BESPONSA was studied in patients who were Philadelphia chromosome (Ph)–positive or Ph–negative in first or second relapse, or who were refractory to their previous treatment.