Zanubrutinib is approved by FDA for chronic lymphocytic leukemia or small lymphocytic lymphoma

Brukinsa

Share This Post

Feb 2023: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) is approved by FDA for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

SEQUOIA was used to assess effectiveness in CLL/SLL patients who had not received treatment (NCT03336333). A total of 479 patients were randomised 1:1 to receive either zanubrutinib until disease progression or unacceptable toxicity or bendamustine plus rituximab (BR) for 6 cycles in the randomised cohort that included patients without 17p deletion. Progression-free survival (PFS) was the primary efficacy outcome metric, as established by a separate review committee (IRC). In the zanubrutinib arm, the median PFS was not achieved (95% CI: NE, NE), but in the BR arm, it was 33.7 months (95% CI: 28.1, NE) (HR= 0.42, 95% CI: 0.28, 0.63; p=0.0001). For PFS, the estimated median follow-up was 25.0 months. Zanubrutinib was assessed in 110 patients with previously untreated CLL/SLL with a 17p deletion in a different non-randomized cohort of SEQUOIA. IRC reported an overall response rate (ORR) of 88% (95% CI: 81, 94). After a median follow-up of 25.1 months, the median duration of response (DOR) had not yet been attained.

ALPINE assessed the effectiveness in patients with relapsed or refractory CLL/SLL (NCT03734016). 652 participants in total were randomly assigned to either zanubrutinib or ibrutinib. 1 was the median number of previous lines of treatment (range 1-8). ORR and DOR were the primary efficacy outcome measures at this point in the response analysis, according to an IRC. The ORR for the zanubrutinib arm was 80% (95% CI: 76, 85) and for the ibrutinib arm was 73% (95% CI: 68, 78) (response rate ratio: 1.10, 95% CI: 1.01, 1.20; p=0.0264). After a median follow-up of 14.1 months, neither arm had reached the median DOR.

The most frequent side effects of zanubrutinib (30%) included bleeding (42%), lower respiratory tract infection (39%), decreased platelet count (34%), decreased neutrophil count (42%), and musculoskeletal pain (30%). In 13% of individuals, secondary primary malignancies, such as non-skin carcinomas, occurred. 3.7% of patients had atrial fibrillation or flutter, while 0.2% of patients had ventricular arrhythmias grade 3 or above.

Until the disease progresses or there is intolerable toxicity, the recommended zanubrutinib dosage is 160 mg taken orally twice day or 320 mg taken orally once daily.

View full prescribing information for Brukinsa.

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
Polatuzumab
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

https://cancerfax.com/