Jaypirca, a New BTK Inhibitor, Received FDA Accelerated Approval for Relapsed or Refractory Mantle-Cell Lymphoma

JHOP - February 2023 Vol 13, No 1 - FDA Oncology Update

On January 27, 2023, the FDA accelerated the approval of pirtobrutinib (Jaypirca; Eli Lilly) for the treatment of patients with relapsed or refractory mantle-cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a BTK inhibitor. The FDA granted this indication an orphan drug designation.

This approval was based on results of the BRUIN study, an open-label, multicenter, single-arm clinical trial with pirtobrutinib monotherapy. The study included 120 patients with MCL who had received a BTK inhibitor; 93% of them received ≥2 previous lines of BTK inhibition, including ibrutinib (67%), acalabrutinib (30%), or zanubrutinib (8%). In all, 83% of the patients had discontinued their last BTK inhibitor because of progressive or refractory disease. All patients received pirtobrutinib orally 200 mg once daily until disease progression or unacceptable adverse events.

The main efficacy measures were overall response rate (ORR) and duration of response (DOR). The ORR was 50% (95% confidence interval [CI], 41-59), with a 13% complete response rate. At 6 months, the estimated DOR rate was 65.3% (95% CI, 49.8-77.1), with an estimated median DOR of 8.3 months (95% CI, 5.7-not estimable).

“Jaypirca offers a new approach to targeting the BTK pathway following treatment with a covalent BTK inhibitor,” said Michael Wang, MD, Puddin Clarke Endowed Professor of Lymphoma and Myeloma, MD Anderson Cancer Center, Houston, TX.

The most common (≥15%) adverse reactions were fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. The most common (≥10%) grade 3 or 4 laboratory abnormalities were decreased neutrophil, lymphocyte, and platelet counts. The prescribing information includes warnings about infections, hemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies.

Related Items
FDA-Approved Nirogacestat Demonstrates Improved Patient Outcomes in Desmoid Tumor Management
Web Exclusives published on February 12, 2024 in FDA Oncology Update
Iwilfin FDA Approved for Adults and Pediatric Patients with High-Risk Neuroblastoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
Welireg Now FDA Approved for Patients with Advanced Renal Cell Carcinoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
Keytruda Plus Chemotherapy Receives New FDA Approvals for Advanced Biliary Tract Cancer and 2 Forms of Advanced Gastroesophageal Junction Adenocarcinoma
Web Exclusives published on December 19, 2023 in FDA Oncology Update
FDA Approved Loqtorzi, a PD-1 Inhibitor, for the Treatment of Adults With Metastatic or Recurrent Nasopharyngeal Carcinoma
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Tibsovo FDA Approved for Patients With Relapsed Myelodysplastic Syndromes and IDH1 Mutation
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Fruzaqla FDA Approved for Refractory Metastatic Colorectal Cancer
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
Rozlytrek Now Approved for Pediatric Patients Older Than 1 Month With Solid Tumors and NTRK Gene Fusion and in New Oral Pellet Form
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
FDA Authorizes Updated COVID-19 Vaccine Formulations for Better Protection Against Current Variants
JHOP - December 2023 Vol 13, No 6 published on November 17, 2023 in FDA Oncology Update
Bosulif Now FDA Approved for Pediatric Patients With Chronic Myelogenous Leukemia
JHOP - December 2023 Vol 13, No 6 published on November 3, 2023 in FDA Oncology Update
© Amplity Health. All rights reserved.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: