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Dailypharm

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Ἶ, Ƽ FDA 㰡û
Ȱ 2020-12-04 12:24:07
Ἶ, Ƽ FDA 㰡û
Ȱ 2020-12-04 12:24:07

CHRYSALIS 1ӻ BLA

'Ƽ' ȭ ġ ݻ 밨

  Ѿ
[ϸ=Ȱ ] Ἶ 'Ƽ' ӻ ǥ׾ ̱ǰǾ౹(FDA) 㰡û Ϸߴ. Ѿ 'Ƽ' Ȱϰ ϰ ִ ׾Ͻž ȭ ӹϸ鼭 'Ƽ' ȭ ġ ȿ ȴ.

Ἶ ׾ȭп Ұ ǥǼڼü(EGFR) (exon) 20 ̼ Ҽ(NSCLC) ȯڿ 'ƹ̹Ÿ(amivantamab)' ϱ FDA ̿Ǿǰ㰡û(BLA) ߴٰ 3(ð) .

'ƹ̹Ÿ' Ἶ ü ׾ü. ϼ Ŀ ߿ ϴ EGFR ߰(MET) Ÿν EGFR , ϴ Ÿ. 3 EGFR 20 ̸ ׾ȿ Ȯ ӻ ̸ Ҽ ȯ 1ӻ󿬱 ͸ FDA ġ(BTD) ޾Ҵ.

Ἶ ̱ӻȸ(ASCO 2020) ǥ CHRYSALIS 1ӻ󿬱 'ƹ̹Ÿ' ܵ ͸ ̹ 㰡û ߴ. EGFR 20 Ұ Ÿ Ҽ ȯ FDA ž㰡û ̷ ù ʴ. ش Ҽ ȯڿ ִ ġ ٴ ߸Ÿ θ ˷. BLA ɻⰣ 'ƹ̹Ÿ' ȯڵ鿡 ϱ α׷(EAP) س ´.

Ἶ 翡 лθ Ѱϴ (Peter Lebowitz) ڻ " 䰡 Ҵ EGFR 20 Ҽ ġῡ ߿ ̷ ǹѴ" "Ϸ绡 ȯڵ ƹ̹Ÿ ֵ α׷ ϰ ִ" ߴ.

迡 ӻ ž ȭ ӵ 鼭 Ѿ 'Ƽ' ȭ ġ ̶ 밨 Ѵ. Ἶ 'ƹ̹Ÿ' 'Ƽ' ߿ ư ִ. Ѿ 'Ƽ' ü 10 9 'ƹ̹Ÿ' 'Ƽ' ϴ CHRYSALIS ۷ι 1/2ӻ ߰, 9 ȸ(ESMO 2020) ȸ ๰ ó ȿ ޾Ҵ.

ESMO 2020 ǥ CHRYSALIS 1bӻ󿬱 ߰м , 'Ƽ' 'ƹ̹Ÿ' EGFR 19 Ǵ L858R ̸ Ҽ ȯڵ  ġ ȯ ׷(20) 'Ÿ׸' Ұ ȯ ׷(45) ο پ . Ư ġ ȯ ๰ġ 7 (ORR) 100% ϸ鼭 аκ ߰ſ ޾Ҵ. ֱٿ 'Ƽ-ƹ̹Ÿ' 'Ÿ׸' ܵ ϴ MARIPOSA ߴ. 2023 'Ƽ' FDA 㰡û ϷѴٴ ǥ.

Ѿ ѱ 'Ƽ' ۷ι DZ ѱ鼭 Ἶκ ȯ ǹ 5000޷( 550) ޾Ҵ. 4 'Ƽ' 'ƹ̹Ÿ' 2ӻ 3500޷ ߰ Ȯߴ. MARIPOSA ӻ ÿ ؼ Ը ȴ. Ѿ 'Ƽ' ȭ ִ ִ 12500޷ Ը. Ƽ ߻ Ѿ ϴ ݰ Ͻ, Ǹ οƼ 40% й޴´.
Ȱ (kjan@dailypharm.com) ٸ
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ֽż ݴ
  • 2020.12.07 16:53:58 |

    ƹ̹Ÿ ̹ 1 btd ޾ egfr ذ Ź ߱ ε... ̰ ߵǸ Ƽ ļ Ǵ° ...

    0 0 0
  • 2020.12.07 16:48:07 |

    ۷ι ƹ̹Ÿ ܵ ûѰɷ µ BLAûߴٰ ߸Ǿִ ׿

    0 0 0
ٺ Ϲݾ ǸŰ (2024 04)
౹ 31
ǰ ְ
ѽŻ÷(10) 3,500 2,500 1,000 3,009
޾(100) 24,000 23,000 1,000 23,200
Ʒγΰ(100) 30,000 28,000 2,000 28,500
īɾ(10g) 7,000 6,000 1,000 6,559
Ľõ򿬰(5g) 5,000 4,500 500 5,138
Ź(4) 5,000 4,000 1,000 4,438
ڶ(20) 6,000 6,000 0 6,000
(10) 6,000 4,500 1,500 5,071
Ժ(10) 4,000 3,500 500 3,712
ڱ׸(20) 5,000 4,500 500 4,717
ť(10) 3,000 2,500 500 2,990
Ȱť(1) 1,200 900 300 1,182
Ǯɾ(3.3ml) 26,000 23,000 3,000 24,250
޵𿬰(10g) 7,000 5,900 1,100 6,289
öŸ(34) 13,000 11,000 2,000 11,866
뽺ī(20g) 22,000 18,000 4,000 20,184
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,500 1,500 9,205
ͺ(10) 3,500 3,000 500 3,196
ݿ(1ڽ) 3,000 3,000 0 3,000
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,524
߽Ÿ(120) 70,000 50,000 20,000 60,385
Źĸ(10ĸ) 3,000 2,000 1,000 2,989
Ÿ̾(120) 60,000 50,000 10,000 51,538
տ(60ĸ) 29,000 25,000 4,000 27,600
Ÿ̷ER(6) 3,000 2,500 500 2,750
ٿ(30g) 12,000 9,000 3,000 11,444
(120) 25,000 22,000 3,000 24,991
Ʒ(6) 4,000 3,000 1,000 3,262
ǽõĸ(270ĸ) 110,000 110,000 0 110,000
B(120) 70,000 70,000 0 70,000
׳(10) 3,000 2,500 500 2,778
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 220,000 10,000 223,333
Ⱦ 12,000 10,000 2,000 10,143
̰źĸ(60ĸ) 35,000 30,000 5,000 33,231
Ųť(20) 5,500 4,500 1,000 4,903
λ絹÷(100) 35,000 32,000 3,000 33,297
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