{"id":819911,"date":"2025-02-28T08:17:48","date_gmt":"2025-02-28T13:17:48","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lillys-jaypirca-pirtobrutinib-recommended-by-chmp-for-approval-in-the-european-union-for-adults-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-previously-treated-with-a-btk-inhibit\/"},"modified":"2025-02-28T08:17:48","modified_gmt":"2025-02-28T13:17:48","slug":"lillys-jaypirca-pirtobrutinib-recommended-by-chmp-for-approval-in-the-european-union-for-adults-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-previously-treated-with-a-btk-inhibit","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lillys-jaypirca-pirtobrutinib-recommended-by-chmp-for-approval-in-the-european-union-for-adults-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-previously-treated-with-a-btk-inhibit\/","title":{"rendered":"Lilly’s Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) previously treated with a BTK inhibitor"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n The positive opinion is based on results from the Phase 3 BRUIN CLL-321 trial, recently presented at the 2024 American Society of Hematology Annual Meeting\u00a0<\/i>\n <\/p>\n

\n BRUIN CLL-321 is the <\/i>
\n first randomized Phase 3 study in CLL ever conducted exclusively in patients previously treated with a BTK inhibitor<\/i>\n <\/p>\n

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\n INDIANAPOLIS<\/span>
\n <\/span>, Feb. 28, 2025<\/span><\/span> \/PRNewswire\/ — Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor,\u00a0for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been previously treated with a BTK inhibitor.<\/p>\n

“Results from the BRUIN CLL-321 trial show that Jaypirca delivers clinically meaningful outcomes in a post-BTK inhibitor setting with markedly prolonged time to next treatment, including in those with high-risk characteristics often associated with poor prognosis,” said Paolo Ghia<\/span>, M.D., professor, medical oncology, Universit\u00e0 Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano<\/span>, Italy.\u00a0“Jaypirca allows for continued targeting of the BTK pathway following treatment with a covalent BTK inhibitor and has the potential to be an important new option in a setting with significant unmet need. The CHMP opinion is an important step toward bringing Jaypirca to patients in the European Union.”<\/p>\n

Following this positive opinion, the application for the use of Jaypirca in patients with relapsed or refractory CLL who have been previously treated with a BTK inhibitor is now referred to the European Commission for final action. The European Commission’s decision is expected in the next one to two months. Jaypirca has also previously received a conditional marketing authorization by the EMA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a BTK inhibitor.<\/i><\/p>\n

The positive opinion is supported by data from the BRUIN CLL-321 clinical trial, the first randomized Phase 3 study in CLL ever conducted exclusively in patients previously treated with a BTK inhibitor. The study’s primary endpoint of progression-free survival (PFS) was met at the prespecified time of final analysis (Aug. 29, 2023<\/span>), based on independent review committee (IRC) assessment, demonstrating pirtobrutinib was superior to investigator’s choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR), both global standards of care.1<\/sup> At an updated analysis (Aug. 29, 2024<\/span>), pirtobrutinib reduced the\u00a0risk of disease progression\u00a0or death by 46% compared to IdelaR or BR\u00a0(median PFS: 14.0 vs. 8.7 months), consistent with the primary analysis.\u00a0PFS results were consistent across key subgroups, including patients who received prior venetoclax and across subgroups associated with poor prognosis, including those with TP53 mutations and\/or 17p deletions, unmutated IGHV status and complex karyotype. Additionally, the median time to next treatment or death (TTNT), a prespecified, descriptive secondary endpoint in the trial that can serve as a surrogate marker for disease control outcomes, was 24 months compared to the control arm of 11 months (63% improvement; HR=0.37 [95% CI, 0.25-0.52]).\u00a0The overall safety profile for patients treated with pirtobrutinib in BRUIN CLL-321 was consistent with safety data from the Phase 1\/2 BRUIN study, including adverse events of special interest.\u00a0The most common adverse reactions of any grade were neutropenia, fatigue, diarrhea, anemia, rash, and contusion.<\/p>\n

Results from the BRUIN CLL-321 study were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2024<\/span>.<\/p>\n

“We are pleased to receive a positive opinion from the CHMP, signaling that the European Union may lead the way in broadening patient access to Jaypirca for those with relapsed or refractory CLL in the post-BTK inhibitor setting,” said Jacob Van Naarden<\/span>, executive vice president and president of Lilly Oncology. “There are currently no treatment options that have been specifically studied in a randomized Phase 3 trial in this patient population, and we are hopeful Jaypirca will be a meaningful new option for patients. We look forward to the European Commission’s decision in the coming months.”<\/p>\n

In addition to this positive opinion in CLL and conditional approval in MCL in the EU, Jaypirca was approved in the U.S. in 2023 under the U.S. Food and Drug Administration’s (FDA)\u00a0Accelerated Approval pathway for the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy, including a BTK inhibitor, and adult patients with CLL or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy including a BTK inhibitor and BCL-2 inhibitor. Lilly has submitted supplemental marketing applications for Jaypirca in the post-BTK inhibitor setting for CLL\/SLL patients around the globe, including in the U.S.<\/p>\n

\n About BRUIN CLL-321<\/b>\u00a0
BRUIN CLL-321 is a Phase 3, randomized, open-label study of pirtobrutinib versus investigator’s choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pre-treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial enrolled 238 patients, who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or investigator’s choice of either IdelaR or BR per labeled doses. This trial’s primary endpoint is progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, as assessed by blinded independent review committee (IRC). Secondary endpoints include PFS, as assessed by investigator; overall response rate (ORR) and duration of response (DoR); event-free survival; overall survival (OS) and time to next treatment (TTNT); safety and tolerability; and patient-reported outcomes (PRO).\u00a0<\/p>\n

\n About Jaypirca (pirtobrutinib)<\/b>\u00a0
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.2<\/sup> BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).3,4<\/sup> Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.<\/p>\n

\n About Chronic Lymphocytic Leukemia (CLL) <\/b>
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CLL is a form of slow-growing non-Hodgkin lymphoma that develops from white blood cells known as lymphocytes.5,6<\/sup> CLL is one of the most common types of leukemia in adults.5 <\/sup>\u00a0There are roughly 100,000 new cases of CLL globally each year, and the overall incidence of CLL in Europe<\/span> is approximately 4.92 cases per 100,000 persons per year.7,8\u00a0 <\/sup>In CLL, the cancer cells are present in the blood.5 <\/sup><\/p>\n

\n INDICATIONS FOR JAYPIRCA (pirtobrutinib) (in the United States<\/span>)
<\/b>Jaypirca is a kinase inhibitor indicated\u00a0for the treatment of<\/p>\n