en.Wedoany.com Reported - The Japanese Ministry of Health, Labour and Welfare has approved bevacizumab (Avastin) as an additional indication for neurofibromatosis type 2, making it the first drug globally approved to treat this disease.

This approval is based on data from the BeatNF2 study (jRCT2080224914). This investigator-initiated, multicenter, randomized, double-blind, placebo-controlled Phase II trial was conducted in Japan, involving 12 institutions and enrolling 62 patients. Patients received Avastin or placebo every two weeks through Week 22; from Week 24 to Week 46, all patients were switched to Avastin treatment. If the treating physician determined disease progression, up to six additional doses could be administered during the follow-up period.

The primary endpoint of the study was the proportion of patients with improved hearing, as measured by the maximum speech recognition score at Week 24. This proportion was 16.1% (5/31; 95% CI 5.5–33.7) in the Avastin group and 3.2% (1/31; 95% CI 0.1–16.7) in the placebo group (P = 0.0858). Secondary analyses showed improvements in hearing measurement indicators and a trend toward reduced tumor volume during treatment.

For neurofibromatosis type 2, the recommended dose for adult patients is 5 mg/kg administered intravenously every two weeks. Among patients receiving Avastin, 57.4% (35/61) reported adverse reactions, with hypertension being the most common, occurring at a rate of 18.0% (11/61).

This article is compiled by Wedoany. All AI citations must indicate the source as "Wedoany". If there is any infringement or other issues, please notify us promptly, and we will modify or delete it accordingly. Email: news@wedoany.com