Case · Eli Lilly (NYSE: LLY) · Jaypirca (pirtobrutinib) · mantle cell lymphoma and CLL/SLL

Jaypirca: what changed in the evidence behind four FDA decisions.

Between January 2023 and October 2026 the FDA approved Jaypirca (pirtobrutinib) four times: two accelerated approvals on response rates from one single-arm study, a conversion to traditional approval on a randomized trial, and a new indication in previously untreated CLL/SLL on a second randomized trial. What each decision rested on, what the FDA said about it, what changed and what did not, read from the FDA's letters, labels and review and Lilly's SEC filings.

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What changed in the evidence behind Jaypirca's FDA approvals?2023 – 2026What changed in the evidencebehind Jaypirca's FDAapprovals?9 documents · 6 connectedWhat evidence did the FDA rely on when Jaypirca first received accelerated approval?JAN 2023What evidence did the FDArely on when Jaypirca firstreceived acceleratedapproval?4 documents · 3 connectedWhat uncertainty did the FDA's reviewers record when they approved Jaypirca in 2023?OCT 2021 – JAN 2023What uncertainty did theFDA's reviewers record whenthey approved Jaypirca in2023?2 documents · 3 connectedWhat evidence supported Jaypirca's accelerated approval in CLL/SLL?DEC 2023What evidence supportedJaypirca's acceleratedapproval in CLL/SLL?4 documents · 5 connectedWhat evidence allowed the FDA to convert Jaypirca's CLL/SLL approval to traditional approval?DEC 2025What evidence allowed the FDAto convert Jaypirca's CLL/SLLapproval to traditionalapproval?5 documents · 7 connectedDid the traditional approval cover the same patients as the accelerated approval?DEC 2023 – DEC 2025Did the traditional approvalcover the same patients asthe accelerated approval?4 documents · 3 connectedWhat did the CLL/SLL confirmatory trial show beyond progression-free survival?DEC 2025What did the CLL/SLLconfirmatory trial showbeyond progression-freesurvival?3 documents · 2 connectedWhat evidence supported Jaypirca's approval in previously untreated CLL/SLL?OCT 2026What evidence supportedJaypirca's approval inpreviously untreated CLL/SLL?4 documents · 3 connectedHow do Jaypirca's four FDA decisions compare, side by side?2023 – 2026How do Jaypirca's four FDAdecisions compare, side byside?10 documents · 5 connectedDid each approval build on the last, or rest on a new body of evidence?2023 – 2026Did each approval build onthe last, or rest on a newbody of evidence?5 documents · 2 connectedWhat stayed the same across Jaypirca's approvals?2023 – 2026What stayed the same acrossJaypirca's approvals?6 documents · 5 connectedWhere does the confirmatory trial for Jaypirca's first indication stand?JAN 2023 – OCT 2026Where does the confirmatorytrial for Jaypirca's firstindication stand?7 documents · 5 connectedHow did Lilly describe each FDA decision on Jaypirca?FEB 2023 – FEB 2026How did Lilly describe eachFDA decision on Jaypirca?9 documents · 3 connectedWhat changed in the evidence behind Jaypirca's FDA approvals?2023 – 2026What changed in the evidencebehind Jaypirca's FDA approvals?What evidence did the FDA rely on when Jaypirca first received accelerated approval?JAN 2023What evidence did the FDA rely onwhen Jaypirca first receivedaccelerated approval?What uncertainty did the FDA's reviewers record when they approved Jaypirca in 2023?OCT 2021 – JAN 2023What uncertainty did the FDA'sreviewers record when theyapproved Jaypirca in 2023?What evidence supported Jaypirca's accelerated approval in CLL/SLL?DEC 2023What evidence supportedJaypirca's accelerated approvalin CLL/SLL?How did Lilly describe each FDA decision on Jaypirca?FEB 2023 – FEB 2026How did Lilly describe each FDAdecision on Jaypirca?What evidence allowed the FDA to convert Jaypirca's CLL/SLL approval to traditional approval?DEC 2025What evidence allowed the FDA toconvert Jaypirca's CLL/SLLapproval to traditional approval?Did the traditional approval cover the same patients as the accelerated approval?DEC 2023 – DEC 2025Did the traditional approvalcover the same patients as theaccelerated approval?How do Jaypirca's four FDA decisions compare, side by side?2023 – 2026How do Jaypirca's four FDAdecisions compare, side by side?What did the CLL/SLL confirmatory trial show beyond progression-free survival?DEC 2025What did the CLL/SLL confirmatorytrial show beyondprogression-free survival?What evidence supported Jaypirca's approval in previously untreated CLL/SLL?OCT 2026What evidence supportedJaypirca's approval in previouslyuntreated CLL/SLL?Where does the confirmatory trial for Jaypirca's first indication stand?JAN 2023 – OCT 2026Where does the confirmatory trialfor Jaypirca's first indicationstand?Did each approval build on the last, or rest on a new body of evidence?2023 – 2026Did each approval build on thelast, or rest on a new body ofevidence?What stayed the same across Jaypirca's approvals?2023 – 2026What stayed the same acrossJaypirca's approvals?

Prepared from public FDA letters and SEC filings: every quoted passage is matched to the original document, and every “not in” statement comes from a search of the whole document, before it is published. Questions, summaries and connecting sentences are EphemerisX’s wording. Not investment advice. How this research works → · Ask the FDA and SEC Ephemeris →