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A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

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Trial Profile

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2026

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At a glance

  • Drugs Pirtobrutinib (Primary) ; Ibrutinib
  • Indications Chronic lymphocytic leukaemia
  • Focus Expanded access; Registrational; Therapeutic Use
  • Acronyms BRUIN-CLL-314
  • Sponsors Loxo Oncology

Most Recent Events

  • 28 Sep 2026 According to an Innovent Biologics media release, based on results from BRUIN CLL-313 and BRUIN CLL-314, the China National Medical Products Administration (NMPA) has approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets), as a monotherapy for the treatment of adult patient with chronic lymphocytic leukemia, small lymphocytic lymphoma.
  • 26 Jun 2026 According to an Eli Lilly and Company media release, Lilly has also submitted these results to the U.S. Food and Drug Administration (FDA) for approval for adult patients with CLL, with a decision expected in the second half of 2026.
  • 26 Jun 2026 According to an Eli Lilly and Company media release, based on results from BRUIN CLL-313 and BRUIN CLL-314, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib). The European Commission's decision is expected in the next one to two months.

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