Loxo@Lilly, Eli Lilly and Company’s oncology division, has received US FDA approval for Jaypirca (pirtobrutinib, 100 mg and 50 mg tablets) to treat 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.
Based on the response rate from the international, open-label, single-arm Phase 1/2 study known as the BRUIN trial, Jaypirca received FDA Accelerated Approval. In a confirmatory trial, clinical benefit verification and description may be required for continued approval for this indication.
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor that uses a novel binding mechanism and is a highly selective kinase inhibitor. Jaypirca can extend the benefits of targeting the BTK pathway by re-establishing BTK inhibition in MCL patients who were previously treated with a covalent BTK inhibitor.
Michael Wang, Professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, said that, the approval of Jaypirca represents an important advance for patients with relapsed or refractory MCL, who currently have limited options and historically have had a poor prognosis following the discontinuation of treatment with a covalent BTK inhibitor.
Michael Wang added that these data show that Jaypirca can be effective in patients who have previously been treated with a covalent BTK inhibitor, potentially increasing the amount of time that patients can benefit from BTK inhibition therapy. After treatment with a covalent BTK inhibitor, Jaypirca offers a novel strategy for focusing on the BTK pathway. It has the potential to significantly change the way MCL patients who have relapsed or are no longer responding to treatment are treated.
Infections, hemorrhage, cytopenias, atrial fibrillation and flutter, secondary primary malignancies, and embryo-fetal toxicity are all mentioned in Jaypirca’s labeling. For additional information, including dosing adjustments, see the full Prescribing Information and Important Safety Information below.
Jacob Van Naarden, chief executive officer of Loxo@Lilly, said that they are pleased to bring a meaningful new therapeutic option to patients with MCL that can re-establish the benefit of targeting the BTK pathway after receiving multiple prior therapies, including a covalent BTK inhibitor.
Jacob Van Naarden added that they appreciate the contributions made by patients, researchers, and other clinical care team members. Their team has been dedicated to rapidly developing Jaypirca for MCL patients, and they hope to build on this milestone by continuing to develop important new treatments for hematologic cancer patients.
