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Eli lilly
NEWS

The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL

Shots: The US FDA has approved an additional indication for Jaypirca (pirtobrutinib, 100 & 50mg) for the treatment of adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion Approval was based on the P-III (BRUIN CLL-313) trial data P-III assessing Jaypirca (200mg, PO, QD until disease progression…
October 5, 2026

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Innovent
NEWS

Innovent Reports NMPA Approval for Jaypirca (Pirtobrutinib) to Treat CLL/ SLL

Shots: The NMPA has approved Jaypirca (100 & 50mg) as a monotx. for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), expanding its use across all lines of therapy & regardless of prior covalent BTK inhibitor treatment Approval was backed by the P-III trials: BRUIN CLL-313 assessed Jaypirca in 282 pts with treatment-naïve…
September 29, 2026

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Eli lilly
NEWS

Eli Lilly Reports P-III (BRUIN CLL-322) Trial Data on Jaypirca Combination for CLL/SLL

Shots: The P-III (BRUIN CLL-322) trial assessed Jaypirca + venetoclax & rituximab vs venetoclax & rituximab in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), with both arms treated ~2yrs. followed by therapy-free period until disease progression The trial met its 1EP, demonstrating improved PFS per IRC, with consistent results across clinically relevant subgroups…
April 14, 2026

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Innovent
NEWS

Innovent Receives the NMPA Approval for Jaypirca to Treat R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The Chinese NMPA has approved Jaypirca (pirtobrutinib) for the treatment of adults with r/r CLL/SLL after ≥1L of systemic therapy incl. a BTK inhibitor Approval was based on the P-III (BRUIN CLL‑321) study assessing Jaypirca monotx. (200mg, PO, QD) vs investigator’s choice of IdelaR or BR in 238 previously treated pts with r/r CLL/SLL Trial…
March 3, 2026

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Eli lilly
NEWS

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD; n=141) vs bendamustine + rituximab (n=141) in 282 treatment-naïve CLL/SLL pts without 17p deletions As of Jul 11, 2025, trial met its 1EP of improved IRC-assessed PFS by 80% with benefits seen across all high-risk subgroups & investigator assessments at…
December 10, 2025

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Eli lilly
NEWS

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…
December 4, 2025

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Eli lilly
NEWS

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD) vs chemoimmunotherapy (bendamustine + rituximab) in 282 pts with 1L chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions Trial met its 1EP of improved PFS per IRC, while OS was immature but showed a favorable trend &…
September 8, 2025

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Eli lilly
NEWS

Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL

Shots: The P-III (BRUIN CLL-314) trial assessed Jaypirca vs Imbruvica in 650 pts with treatment-naïve or experienced (but BTK-naïve) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Trial met its 1EP of ORR non-inferiority in both pre-treated & ITT pts, with ORR favoring Jaypirca; PFS was immature but showed favorable trend, especially in treatment-naïve pts…
July 30, 2025

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