Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia
January 23, 2023FDA has approved Orserdu for the treatment of postmenopausal
January 30, 2023January 27, 2023 - Loxo@Lilly, the oncology unit of Eli Lilly and Company announced that the U.S. Food and Drug Administration approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
Jaypirca, a highly selective kinase inhibitor, utilizes a novel binding mechanism and is the first and only FDA approved non-covalent (reversible) BTK inhibitor. It was approved under the FDA's Accelerated Approval pathway based on response rate from the open-label, single-arm, international, Phase 1/2 study, called the BRUIN trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Jaypirca is expected to be available in the United States in the coming weeks.