[ij] ڸ, CAR-T ġ 'Ķ', ɾ []
簡 REMS κ ...ټ Ȯ
2019-08-09
̱ ɾ `CAR-T ġ` ǷẸ ƴ.
̱ ɾ ο 65 ̻ ùα Ǵ ֱڿ ϴ ǰ̴.
FDA ȭ (REMS) ⸸ Ѵٸ, κ Ƿ CAR-T ġ .
̴ ġ Ǹŷ ް ִ CAR-T ġ 鿡Դ ҽ̴.
ɾ (Centers for Medicare and Medicaid Services, CMS) ؿ , CAR-T ġ ٰŻ Ǻ (Coverage with Evidence Development, CED) ƴ.
Ư CAR-T ġ , ش ġ ִ 2 ȯ , ļ ġ ؾߴ.
̷ δ ƴ, Ƽ 渮 FDA ȭ (Risk Evaluation and Mitigation Strategy, REMS) ϰ ȴ.
REMS ۿ Ǿǰ ȯ ϴ . ɰ ۿ Ǵ Ǿǰ 簡 REMS Ȯϵ ϰ ִ.
ݱ ȭ CAR-T ġ ȯ T , ϼ ν ִ ü ϰ Ľ ȯ ӿ ִ ڰ ̴.
ϴµ 2~3ְ ҿǰ, 븸 15 ~35 ʿϴ. Դٰ ̷ ش ȯڿԸ ۿ ܰ ߴ Ұɿ .
CAR-T ġ ġ ۿ ֱ κ ȯڴ Կ , ļġ Ⱓ ʿϴ. ̷ Ǹ ġ ܿ ߰ ప 2 ̻ ִ.
ġ ü ʾ, ҵǴ 50%~65% λȴ. ̴ CAR-T ġ ȯ ټ ų ִ.