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.
