Jaypirca (pirtobrutinib) was approved by the FDA on October 2, 2026 for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.
Lilly says the approval allows Jaypirca to be used as a first-line treatment for appropriate patients with CLL or SLL. It was already approved for relapsed or refractory CLL/SLL in adults previously treated with a covalent BTK inhibitor and, under accelerated approval, for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. Recommended dose: 200 mg orally once daily (FDA).
The FDA's approval notification is dated October 2, 2026 and states the approval was made that day; Eli Lilly and Company announced it the same day (Lilly's announcement). The approval is based on BRUIN CLL-313 (NCT05023980), a randomized, open-label, active-controlled trial in 282 patients with previously untreated CLL/SLL without deletion of chromosome 17p, comparing pirtobrutinib (141 patients, until disease progression) with bendamustine plus a rituximab product (141 patients, six cycles). Per the FDA, progression-free survival assessed by an independent review committee had a hazard ratio of 0.20 (95% CI 0.11 to 0.37; p<0.0001); median progression-free survival was not estimable in the pirtobrutinib arm and 33.5 months in the bendamustine and rituximab arm, at an estimated median follow-up of 28 months. Overall survival data were immature: 3 deaths (2.1%) in the pirtobrutinib arm and 10 (7.1%) in the control arm at the primary analysis. Serious adverse reactions occurred in 28% of patients taking pirtobrutinib, and the most common non-laboratory adverse reactions (20% or more) were upper respiratory tract infections, rash and COVID-19. Pirtobrutinib received orphan drug designation. In June 2026 Lilly said it had submitted its CLL results (BRUIN CLL-313 and CLL-314) to the FDA, "with a decision expected in the second half of 2026" (Lilly, June 26, 2026); pdufa.bio holds no goal date, so no early or late margin is computed. Earlier FDA approvals of Jaypirca: January 27, 2023 (relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor, accelerated approval), December 1, 2023 (CLL/SLL after at least two prior lines including a BTK inhibitor and a BCL-2 inhibitor, accelerated approval) and December 3, 2025 (traditional approval for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor). The FDA's approval letter for this supplement (NDA 216059) had not yet been posted on Drugs@FDA when this page was published.
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Primary source: FDA approval notification, pirtobrutinib for previously untreated CLL or SLL, October 2, 2026
FDA record of the action: the FDA approved on October 2, 2026, per FDA approval notification, NDA 216059 (FDA notice). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
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Yes. The FDA approved the application for Jaypirca (pirtobrutinib) on October 2, 2026, per the FDA's own record. The primary source is linked on this page.
Jaypirca (pirtobrutinib) is an Eli Lilly and Company (LLY) program. The FDA decision came on October 2, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), LLY moved +23.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
The FDA approved pirtobrutinib (Jaypirca, Eli Lilly and Company) on October 2, 2026 for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion, per the FDA's approval notification of that date.
The FDA first approved Jaypirca on January 27, 2023, under accelerated approval for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. It added CLL/SLL after at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor on December 1, 2023 (accelerated approval), granted traditional approval for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor on December 3, 2025, and approved first-line use in CLL/SLL with no known 17p deletion on October 2, 2026.
BRUIN CLL-313 (NCT05023980), a randomized, open-label, active-controlled trial in 282 patients with previously untreated CLL or SLL without deletion of chromosome 17p, comparing pirtobrutinib with bendamustine plus a rituximab product. Progression-free survival assessed by an independent review committee had a hazard ratio of 0.20 (95% CI 0.11 to 0.37; p<0.0001), per the FDA.
The FDA's notification gives the recommended pirtobrutinib dose as 200 mg orally once daily until disease progression or unacceptable toxicity. The FDA says full prescribing information will be posted on Drugs@FDA; Lilly's announcement links the current prescribing information.