(Lymphoma) FDA Approves CAR-T Therapy Breyanzi
Medical Supporter — Мэдээллийн мэдэгдэл
Энэ нийтлэл нь олон улсын эмнэлгийн мэдээллийн эмхэтгэл бөгөөд эмнэлгийн зөвлөгөө биш; таны эмчийн оношлогоо, эмчилгээний төлөвлөгөөг орлохгүй. Энд буй мэдээлэл нь Японы томоохон эмнэлгийн байгууллагуудын нээлттэй эх сурвалжаас эмхэтгэсэн бөгөөд аливаа эмчилгээний тохиромж, үр дүн өвчтөн бүрээр өөр тул мэргэшсэн эмч тус бүрчлэн үнэлэх ёстой.
- April 19, 2021
- Read time: 1 minute
On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb's CAR-T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) for patients with relapsed or refractory large B-cell lymphoma. This is the third gene therapy approved by the FDA for diffuse large B-cell lymphoma and certain types of non-Hodgkin's lymphoma.
It is indicated for patients with diffuse large B-cell lymphoma and certain types of non-Hodgkin's lymphoma who have received two or more prior systemic therapies with poor outcomes or relapse after treatment. It is not indicated for patients with CNS lymphoma. The FDA has designated it as an Orphan Drug, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT).
Due to potential adverse events such as cytokine release syndrome (CRS) or neurological toxicity, close attention will be paid to whether relevant medical institutions comply with Risk Evaluation and Mitigation Strategy (REMS) requirements. The FDA will evaluate long-term safety and has required manufacturers to conduct post-market observational studies.
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin's lymphoma in adult patients. In the United States, approximately 77,000 new cases of non-Hodgkin's lymphoma are diagnosed annually, of which one-third are diagnosed as diffuse large B-cell lymphoma.
Source: https://www.mixonline.jp/tabid55.html?artid=70614
- Immunotherapy
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Японд эмчлүүлэхээр төлөвлөж байна уу? Мэдээлэл, тусламж хэрэгтэй юу?
Бид Японд эмчлүүлэхэд шаардлагатай мэдээллийг эмхэтгэх, Японы эмнэлгийн байгууллагуудтай холбогдох, хоёр дахь саналын зөвлөгөө зохион байгуулахад тусална.Анхны зөвлөгөө үнэгүй; зөвлөх таны дараагийн алхмыг тодорхой болгоход тусална.
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