Accelerated approval is granted by FDA to pirtobrutinib for relapsed or refractory mantle cell lymphoma

Jayprica Lilly

Share This Post

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%), acalabrutinib (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.

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).

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.

View full prescribing information for Jaypirca.

Spread the love

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Development of CAR T Cell therapy in Korea
Cancer treatment in South Korea

Companies in Korea takes a step closer in developing home grown CAR T-Cell therapy

Due to high costs, treatments developed by multinational pharmaceutical corporations are difficult for Korean patients to access. As a result, Korean businesses have created and localised CAR-T treatments in an effort to address these issues. Many businesses have either begun developing CAR-T therapies or declared their intention to do so, including Curocell, Abclon, GC Cell, Ticaros, Helixmith, Toolgen, Cllengene, Eutilex, and Vaxcell Bio.

Spread the love
Blood cancer

Polatuzumab vedotin-piiq is approved by USFDA for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

For adult patients with high-grade B-cell lymphoma (HGBL), not otherwise specified (NOS), or diffuse large B-cell lymphoma (DLBCL) who have not previously received treatment and who have an International Prognostic Index (IPI) score of 2 or higher, the Food and Drug Administration has approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.).

Spread the love

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

درمان سرطان در تركيه

Enquiry Form