US EditionFDA expands pirtobrutinib use in chronic lymphocytic leukemia, small lymphocytic lymphoma
The FDA converted Jaypirca's accelerated approval to traditional based on BRUIN CLL-321 trial data showing 42% of patients crossed over to Jaypirca with improved progression-free survival.
- The U.S. Food and Drug Administration granted traditional approval to pirtobrutinib , converting December 2023 accelerated approval and expanding its label to earlier use in relapsed CLL/SLL.
- The FDA cited results from the BRUIN CLL-321 randomized trial, which enrolled patients previously treated with covalent Bruton tyrosine kinase inhibitors and showed improved progression-free survival assessed by a blinded independent review committee.
- Prescribing information sets the recommended 200 mg orally once daily dose until disease progression or unacceptable toxicity, with warnings for infections, hemorrhage, cytopenias, cardiac arrhythmias, secondary malignancies, hepatotoxicity and embryo-fetal toxicity.
- Commercially, Jaypirca has shown rapid uptake with sales rising 76% to $143 million, and GlobalData projects it could reach about $3 billion with nearly 60% market share by 2032.
- Trial crossover — 42% of control patients — complicates survival comparisons, but Jeff Sharman highlighted `Pirtobrutinib is the only medicine in CLL or SLL that has been prospectively studied in a randomised trial` as expanding FDA approval.
21 Articles
21 Articles
The Chandler Arizonan
U.S. FDA approves expanded indication for Lilly's Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor
Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with a covalent BTK inhibitor
FDA expands pirtobrutinib use in chronic lymphocytic leukemia, small lymphocytic lymphoma
The FDA has approved pirtobrutinib for certain adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.The new indication applies to adults who previously have been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor, expanding on the 2023 accelerated approval for pirtobrutinib (Jaypirca, Eli Lilly and Co.) for patients who had received at least
FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL
This applies to patients previously treated with a covalent Bruton tyrosine kinase (BTK) inhibitor. The approval broadens Jaypirca’s label to cover patients at an earlier stage of treatment The post FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL appeared first on Pharmaceutical Business review.
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