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A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Trial Profile

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Sep 2026

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At a glance

  • Drugs Pirtobrutinib (Primary) ; Bendamustine; Rituximab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms BRUIN CLL-313
  • Sponsors Loxo Oncology

Most Recent Events

  • 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.
  • 22 Jan 2026 Planned End Date changed from 1 Aug 2026 to 1 Oct 2027.

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