The United States Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca), a noncovalent Bruton’s tyrosine kinase inhibitor, for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received a covalent BTK inhibitor. This approval converts the 2023 accelerated approval for patients after at least two prior lines, including a BTK inhibitor and BCL-2 inhibitor.
The approval is based on the phase 3 BRUIN-CLL-321 trial (NCT04666038), which randomized previously treated patients to pirtobrutinib or investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab. Pirtobrutinib extended progression-free survival compared with the control arm; the median PFS was 11.2 months in the pirtobrutinib arm and 8.7 months in the investigator’s choice of IR/BR arm, according to a press release from Eli Lilly, the manufacturer of the drug.
The review used the Assessment Aid, a voluntary submission from the applicant to facilitate FDA assessment. Pirtobrutinib also carries Orphan Drug Designation.
The European Medicines Agency’s CHMP has issued a positive opinion recommending approval of pirtobrutinib for the same population.
