The Food and Drug Administration (FDA) granted an accelerated approval to Jaypirca (pirtobrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia (CLL and SLL, respectively) who have received two or more prior lines of therapy, including a BTK and a BCL-2 inhibitor, according to the agency.
“Once patients with CLL or SLL Have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be poor, making the approval of Jaypirca a meaningful advance and much-needed new treatment option for these patients,” Dr. William G. Wierda, professor, medical director and CLL section hear for the department of leukemia at The University of Texas MD Anderson Cancer Center in Houston, said in a press release from Eli Lilly, the manufacturer of Jaypirca.
The approval was based off findings from the international BRUIN trial, which included 108 patients with CLL or SLL who were previously treated with a median of five prior lines of therapy (range, two to 11), the majority of whom discontinued their last BTK inhibitor either because their disease stopped responding to treatment or their disease got worse on treatment.
In the trial, Jaypirca was given orally until patients’ disease progressed or until side effects became intolerable.
The main goal of the BRUIN trial was to measure overall response rate (ORR; percentage of patients whose disease shrinks or disappears) and duration of response. Findings showed that the ORR was 72%, and the median duration of response was 12.2 months. Of note, all responses were partial responses, meaning that patients’ disease shrunk but did not completely disappear.
“Jaypirca offers a new treatment option and different approach to targeting BTK, providing clinical benefit for a high proportion of patients with CLL or SLL in the bruin phase 1/2 trial hose disease progressed following treatment with a covalent BTK inhibitor and with a BCL-2 inhibitor,” said Wierda in the release.
The most common side effects, excluding laboratory terms, that occurred in at least 20% of patients were fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, difficulty breathing, hemorrhage (bleeding), edema (swelling), nausea, fever and headache.
Moderate to severe laboratory abnormalities in more than 10% of patients included decreased neutrophil counts, anemia and decreased platelet counts. Serious infections occurred in 32% of patients including fatal infections in 10% of patients. The prescribing information includes warnings and precautions for infections, hemorrhage, cytopenias (low levels of red and white blood cells, and platelets), cardiac arrhythmias (irregular heartbeat) and secondary primary malignancies.
Since the drug was granted an accelerated approval, research must continue to ensure Japirca is safe and efficacious, according to the agency.
“The treatment landscape for CLL Has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors,” Dr. Brian Koffman, chief medical officer and executive vice president at the CLL Society, said in the Eli Lilly press release. “(Jaypirca’s) approval gives patients a much-needed option and brings forward new possibilities as they continue their treatment journey.”
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