JAYPIRCA^™

FOR IMMEDIATE RELEASE:

JAYPIRCA™ (pirtobrutinib) Now Available from Onco360 for the Treatment of Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma (MCL) after at least Two Lines of Systemic Therapy, Including a BTK Inhibitor

Louisville, KY — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected by Eli Lilly to be a specialty pharmacy partner for JAYPIRCA™ (pirtobrutinib), which is a kinase inhibitor indicated 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 inhibitor (BTKi). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

“Onco360 is excited to announce our partnership with Eli Lilly and become a specialty pharmacy provider for JAYPIRCA patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “We are committed to supporting the highly specialized needs of patients battling relapsed/refractory mantle cell lymphoma which has failed prior lines of systemic therapy across the United States.”

According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 80,470 new cases of Non-Hodgkin Lymphoma (NHL) will be diagnosed in 2022 in the United States with a corresponding 20,250 deaths in 2022.¹ According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of B-Cell Lymphomas, 3-5% of annual new NHL diagnoses are mantle cell lymphoma (MCL) cases. MCL is thought to possess the unfavorable characteristics of both indolent and aggressive NHL subtypes owing to the incurability of disease with conventional chemotherapy and a typically more aggressive disease course compared to indolent lymphomas. The five-year overall survival (OS) for MCL ranges from 50-70% dependent upon stage of disease.²

JAYPIRCA, a non-covalent BTKi, is commercialized by Eli Lilly.. The FDA approval of JAYPIRCA is based on results Phase I/II BRUIN trial (NCT03740529), which was an open-label, single-arm study that, in part, evaluated the efficacy/safety of JAYPIRCA in 120 patients with relapsed/refractory MCL who were previously treated with BTKi therapy. JAYPIRCA administration resulted in a 50% overall response rate (ORR) in the aforementioned patient population. The most common adverse reactions (> 15%) in patients with MCL are fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising.³

References:

• Non-Hodgkin Lymphoma — Cancer Stat Facts accessed 1/30/23
• b-cell.pdf (nccn.org) accessed 1/30/23
• Mantle Cell Lympoma (MCL) Treatment | Jaypirca™ (pirtobrutinib)

Media Contact:

Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332