Jaypirca (pirtobrutinib) is an ELI LILLY & Co program in adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion. The FDA approved it on Oct 2, 2026. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion (approved Oct 2, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: ELI LILLY & Co (LLY). Approval record: Supplemental NDA 216059 for first-line use. BRUIN CLL-313 (NCT05023980): 282 previously untreated patients without 17p deletion, randomized 1:1 to pirtobrutinib or bendamustine plus rituximab; IRC-assessed PFS hazard ratio 0.20 (95% CI 0.11 to 0.37), median PFS not estimable vs 33.5 months at a median follow-up of 28 months; OS immature. 200 mg orally once daily. Orphan drug designation (FDA notification). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 257,900 | $309.3 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for Jaypirca (pirtobrutinib); 2 FDA decisions are on record below.
On Oct 2, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Jaypirca (pirtobrutinib) is FDA-approved for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion (approved Oct 2, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
ELI LILLY & Co (LLY).
Yes. The FDA approved an application for Jaypirca (pirtobrutinib) on Oct 2, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.