- FDA approves Jaypirca for relapsed or refractory CLL/SLL after covalent BTK inhibitor treatment.
- Approval based on BRUIN CLL-321 trial, the only Phase 3 study with prior covalent BTK inhibitor treatment.
- Jaypirca is a non-covalent BTK inhibitor, offering a new option for CLL/SLL patients.
- Lilly is conducting multiple Phase 3 studies on Jaypirca for CLL/SLL.
FDA Approval
The U.S. FDA has approved Jaypirca (pirtobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor. This approval expands the drug's label to include patients earlier in their treatment course.
Clinical Trial Basis
The approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL where all patients had prior treatment with a covalent BTK inhibitor. This trial demonstrated the efficacy and safety of Jaypirca in this specific patient group.
Mechanism of Action
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor. It is a highly selective kinase inhibitor that uses a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in patients with relapsed or refractory CLL/SLL.
Future Research
Lilly is conducting multiple Phase 3 studies to further investigate the efficacy and safety of Jaypirca in CLL/SLL. Details on these trials can be found on clinicaltrials.gov.
