The FDA has approved zanubrutinib for the treatment of Waldenstrom’s macroglobulinemia

Share This Post

September 2021: For adult patients with Waldenström’s macroglobulinemia, the FDA has approved zanubrutinib (Brukinsa, BeiGene) (WM).

In ASPEN (NCT03053440), zanubrutinib was compared to ibrutinib in patients with MYD88 L265P mutation (MYD88MUT) WM. Cohort 1 (n=201) patients were randomly assigned to receive either zanubrutinib 160 mg twice day or ibrutinib 420 mg once daily until disease progression or intolerable toxicity. Patients in Cohort 2 were given zanubrutinib 160 mg twice daily and were either MYD88 wildtype (MYD88WT) or MYD88 mutation unknown WM (n=26 and 2, respectively).

Response rate, defined as a partial response (PR) or better as judged by an independent review committee using conventional consensus response criteria from the International Workshop on Waldenström’s Macroglobulinemia-6, was the primary efficacy outcome used to support approval. The length of reaction was another efficacy outcome metric (DOR).

The zanubrutinib arms were approved based on a non-comparative evaluation of response and DOR. The zanubrutinib arm had a response rate of 77.5 percent (95 percent confidence interval: 68.1,85.1). The zanubrutinib group had a 94.4 percent event-free DOR at 12 months (95 percent CI: 85.8, 97.9). Response (CR+VGPR+PR) was detected in 50% of the Cohort 2 participants, according to IRC (13 out of 26 response evaluable patients; 95 percent CI: 29.9, 70.1).

Neutrophil count decreased, upper respiratory tract infection, platelet count decreased, rash, haemorrhage, musculoskeletal pain, haemoglobin decreased, bruising, diarrhoea, pneumonia, and cough are the most common adverse reactions, including laboratory abnormalities, reported with zanubrutinib (20 percent).

The recommended dose of zanubrutinib is 160 mg twice a day or 320 mg once a day.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Risk of developing secondary tumors following CAR-T cell therapy is minimal - A Stanford Study
CAR T-Cell therapy

Risk of developing secondary tumors following CAR-T cell therapy is minimal – A Stanford Study

CAR-T cell therapy, a groundbreaking cancer treatment, carries a risk of developing secondary tumors. This occurs due to the therapy’s potential to cause genetic mutations or alter the immune system’s regulation. Secondary malignancies can arise from these changes, presenting a significant long-term risk for patients. Continuous monitoring and research are crucial to understanding and mitigating these risks, ensuring safer outcomes for those undergoing CAR-T cell therapy.

Seattle Children's Hospital to Start CAR T-Cell Clinical Trial for Pediatric Lupus Patients
CAR T-Cell therapy

Seattle Children’s Hospital to Start CAR T-Cell Clinical Trial for Pediatric Lupus Patients

Seattle Children’s Hospital is launching a groundbreaking CAR T-cell clinical trial for pediatric lupus patients. This innovative approach harnesses the body’s immune cells to target and eliminate lupus-affected cells, offering new hope for young patients with this autoimmune disorder. The trial represents a significant advancement in lupus treatment, aiming to improve outcomes and reduce long-term complications for children suffering from this challenging condition.

Need help? Our team is ready to assist you.

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

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy