Neurologic toxicity, including ICANS, occurred in 55% of patients who received TALVEY® at the recommended dosages; Grade 3 or 4 events occurred in 6% of patients
- Most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction, including ataxia/cerebellar ataxia (10%)
ICANS was reported in 9% of 265 patients where ICANS data were collected and who received TALVEY® at the recommended dosages
- Recurrent ICANS occurred in 3% of patients
- ICANS can occur concurrently with CRS, following resolution of CRS, or in the absence of CRS
- Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia
- Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve
ICANS experienced after each dose of TALVEY® (n=265)
| Q2W | QW |
|---|
| Step-up dosing schedule |
| Step-up dose 1: 3% |
| Step-up dose 2: 3% |
| Step-up dose 3: 1.8% | First treatment dose (n=156): 2.6% |
| First treatment dose (n=109): 3.7% | N/A |