Overview
- The approval converts Jaypirca’s 2023 accelerated authorization into a traditional approval for adults previously treated with a covalent BTK inhibitor.
- In the randomized BRUIN-CLL-321 trial (n=238), Jaypirca achieved a progression-free survival hazard ratio of 0.58 versus investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab, with median PFS of 11.2 vs 8.7 months.
- Overall survival interpretation remains uncertain, with an updated analysis showing an OS hazard ratio of 1.09 after 42% of control patients crossed over to Jaypirca following progression.
- The recommended dose is 200 mg orally once daily until disease progression or unacceptable toxicity, with label warnings for infections, hemorrhage, cytopenias, arrhythmias, secondary malignancies, hepatotoxicity and embryo–fetal toxicity.
- Use directly after covalent BTK inhibitor treatment is now permitted, and the pivotal study enrolled patients exposed to covalent BTK inhibitors without prior non-covalent BTK inhibitor therapy.