In this article
FDA Accelerated Approval for Mantle Cell Lymphoma
Feb 2023: Accelerated approval is granted by FDA to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma.
In BRUIN (NCT03740529), an open-label, multicenter, single-arm trial of pirtobrutinib monotherapy that comprised 120 MCL patients who had previously received BTK inhibitor treatment, efficacy was assessed. Patients had received a median of three lines of therapy before, with 93% receiving two or more. Ibrutinib (67%), (30%), and zanubrutinib (8%), which were the most frequently prescribed prior BTK inhibitors, were stopped by 83% of patients due to refractory or worsening disease.
Pirtobrutinib was given orally once day at a dose of 200 mg and continued until the disease progressed or the side effects became intolerable.
BRUIN Trial Efficacy and Response Rates
Overall response rate (ORR) and duration of response (DOR), as determined by an independent review committee using the Lugano criteria, were the primary efficacy measures. The ORR was 50% (95% CI: 41, 59) and 13% of respondents completed the survey in full. The estimated DOR rate at 6 months was estimated to be 65.3% (95% CI: 49.8, 77.1), and the estimated median DOR was 8.3 months (95% CI: 5.7, NE).
Safety Profile and Dosage Guidelines
In patients with MCL, fatigue, musculoskeletal discomfort, diarrhoea, edoema, dyspnea, pneumonia, and bruising were the most frequent side effects (15%). Decreased neutrophil, lymphocyte, and platelet counts were grade 3 or 4 laboratory abnormalities in 10% of individuals. Precautions and warnings regarding infections, bleeding, cytopenias, atrial fibrillation and flutter, and second main malignancies are included in the prescribing material.
It is advised to take 200 mg of pirtobrutinib once daily until the disease progresses or the toxicity becomes intolerable.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Susan Hau
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy. Hau's expertise lies in cancer cell biolo…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.