Drugs and FDA
FDA grants accelerated approval to pirtobrutinib for CLL and SLL
Pirtobrutinib is approved for adults with CLL or SLL after at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
The FDA granted accelerated approval to pirtobrutinib, sold as Jaypirca, for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
The FDA assessed the drug in a trial of 108 patients. The overall response rate was 72%, and the median duration of response was 12.2 months. All responses were partial. Serious infections occurred in 32% of patients, including fatal infections in 10%. The prescribing information includes warnings about infections, hemorrhage, low blood counts, cardiac arrhythmias and secondary primary malignancies.
