Jaypirca: what changed in the evidence · Jaypirca · Feb 2023 – Feb 2026
How did Lilly describe each FDA decision on Jaypirca?
As accelerated approvals in 2023, in the FDA's terms. The 2025 conversion appears in its earnings release as an “expanded indication”, and in its 2025 10-K as “Full approval”; the FDA's word is “traditional”.
EphemerisX Research · Published · 9 source documents · 1 min read
Short answer
Lilly's 2023 filings call both approvals accelerated, as the FDA did. For the December 2025 conversion, its February 2026 earnings release reports an “expanded indication” without the words traditional, accelerated or full approval; its 2025 10-K lists Jaypirca in CLL as “Full approval in the U.S., the EU, and Japan.” The FDA's letter and announcement say traditional approval.
What the evidence shows
February 2023: for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor, under the accelerated approval pathway
8-K · Feb 2, 2023. Its 10-K that month: FDA granted accelerated approval (4) in the U.S. in January 2023. Phase III trial is ongoing
10-K · Feb 22, 2023, with the footnote Continued approval may be contingent on verification and description of clinical benefit in confirmatory Phase III trials
10-K · Feb 22, 2023.
August 2023: Submitted in the U.S. in August 2023 under the accelerated approval pathway
10-Q · Aug 8, 2023. February 2024: approval under the Accelerated Approval Program
8-K · Feb 6, 2024.
February 2026, on the December 2025 decision: 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
8-K · Feb 4, 2026. Lilly's fourth-quarter 2025 earnings release does not describe the December 2025 decision as traditional, accelerated or full approval. 8-K · searched
The 10-K eight days later: Full approval in the U.S., the EU, and Japan
10-K · Feb 12, 2026. The FDA's announcement: the Food and Drug Administration granted traditional approval to pirtobrutinib
FDA · Dec 3, 2025. Lilly's filings name one trial, BRUIN CLL-321
8-K · Feb 6, 2025; the 2026 result appears without the trial's name: significantly improved progression-free survival in patients with treatment-naïve CLL/SLL
8-K · Oct 30, 2025.
Lilly's filings through August 2026 do not yet report the October 2026 approval.
Follow the thread
- What evidence allowed the FDA to convert Jaypirca's CLL/SLL approval to traditional approval?BRUIN CLL-321
- Where does the confirmatory trial for Jaypirca's first indication stand?“Phase III trial is ongoing”
- What stayed the same across Jaypirca's approvals?“Non-covalent (reversible)”
The documents, by date
The passages quoted
Lilly Form 8-K, filed February 2, 2023
The U.S. Food and Drug Administration (FDA) approval of Jaypirca TM (pirtobrutinib) for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor, under the accelerated approval pathway;Open at the source →
Lilly Form 10-K, filed February 22, 2023
Continued approval may be contingent on verification and description of clinical benefit in confirmatory Phase III trials.Open at the source →
Lilly Form 10-K, filed February 22, 2023
Pirtobrutinib (Jaypirca TM ) Mantle cell lymphoma Approved (4) FDA granted accelerated approval (4) in the U.S. in January 2023. Phase III trial is ongoing.Open at the source →
Lilly Form 10-Q, filed August 8, 2023
Submitted in the U.S. in August 2023 under the accelerated approval pathway.Open at the source →
Lilly Form 8-K, filed February 6, 2024
FDA approval of Jaypirca ® for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor, under the Accelerated Approval Program;Open at the source →
Lilly Form 8-K, filed February 6, 2025
Positive Phase 3 results from the BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) previously treated with a covalent BTK inhibitor;Open at the source →
Lilly Form 8-K, filed October 30, 2025
Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, significantly improved progression-free survival in patients with treatment-naïve CLL/SLLOpen at the source →
FDA announcement, December 3, 2025
On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.Open at the source →
Jaypirca: what changed in the evidence Form 8-K, filed February 4, 2026
Lilly's fourth-quarter 2025 earnings release does not describe the December 2025 decision as traditional, accelerated or full approval.
Open the document →Lilly Form 8-K, filed February 4, 2026
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 inhibitorOpen at the source →
Lilly Form 10-K, filed February 12, 2026
Pirtobrutinib (Jaypirca) Chronic lymphocytic leukemia Approved Full approval in the U.S., the EU, and Japan.Open at the source →