FDA approves Jaypirca for chronic lymphocytic leukemia, small lymphocytic lymphoma
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The FDA granted accelerated approval to pirtobrutinib for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The indication applies to use of the agent in adults who received at least two previous lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Accelerated approval for the indication is contingent on verification of therapy’s safety and efficacy in a confirmatory clinical trial.
Pirtobrutinib (Jaypirca, Eli Lilly & Co.) — a selective noncovalent BTK inhibitor — previously received orphan drug designation from the FDA and expedited priority review for the indication. The FDA granted accelerated approval to first-in-class therapy earlier this year for the treatment of adults with relapsed or refractory mantle cell lymphoma who received at least two previous lines of systemic therapy, including a BTK inhibitor.
"The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors. However, most patients will unfortunately relapse eventually," Brian Koffman, MDCM, chief medical officer and executive vice president at the CLL Society, said in a Lilly-issued press release. “Pirtobrutinib's approval gives patients a much-needed option and brings forward new possibilities as they continue their treatment journey.”
The FDA based approval on results from a subset of patients in the multicenter phase 1/phase 2 BRUIN trial.
The BRUIN trial included 108 patients with advanced CLL or small lymphocytic lymphoma (SLL) who received at least two previous lines lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Study participants received oral pirtobrutinib 200 mg daily until experiencing disease progression or unacceptable toxicity.
Overall response rate and duration of response served as primary outcome measurements for the phase 2 portion of the study.
At an estimated median follow-up of 15.7 months, results from the BRUIN trial showed an ORR of 72% (95% CI, 63-80), with median duration of response lasting 12.2 months (95% CI, 9.3-14.7).
The most common adverse events related to use of pirtobrutinib included fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, dyspnea, hemorrhage, edema, nausea, pyrexia and headache. Serious infections occurred in 32% of patients who received pirtobrutinib in the BRUIN trial, including fatal infections in 10% of study participants.
The prescribing label for pirtobrutinib contains warnings regarding the risk for infections, hemorrhage, cytopenias, cardiac arrhythmias and secondary primary malignancies associated with its use.
References:
- FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic. Posted Dec. 1, 2023. Accessed Dec. 4, 2023.
- Jaypirca (pirtobrutinib) now approved by U.S. FDA for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor (press release). Available at: https://investor.lilly.com/news-releases/news-release-details/jaypircar-pirtobrutinib-now-approved-us-fda-treatment-adult. Posted Dec. 1, 2023. Accessed Dec. 4, 2023.
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