24.05.23 () 04:35

Dailypharm

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Ʈ 'Ƽ' ӻ ӵ...ѹ ž ѷ
Ȱ 2021-08-09 06:00:52
Ʈ 'Ƽ' ӻ ӵ...ѹ ž ѷ
Ȱ 2021-08-09 06:00:52
[DP]  FDA ž㰡û ...żӽɻ

'Ƽ' ๰ȣۿ ӹ


  ѹ̾ǰ
[ϸ=Ȱ ] Ʈ ѹ̾ǰκ ׾Ͻž 'Ƽ' ȭ ä θ ִ. 'Ƽ' ๰ȣۿ 򰡸 ġ鼭 ̱ǰǾ౹(FDA) ž㰡û ϴ ̴. 'ѷƼ' ߸ 'Ƽ' ο ı .

9 ̱ ǿ(NIH) ϴ ӻϻƮ ŬĮƮ̾ ƮĸƼ ֱ 'Ƽ' ο ӻ Ȳ ߴ.

ǰ ڸ 'Ƽ' 'Ʈڳ', װ '', (SSRI) 迭 ׿ '弼ƾ' پ ๰ ȣۿ ϴ 1ӻ̴. ϵ ڸ 3 Ʈ ๰ ϸ鼭 ൿ(PK) ȭ 캸 д.

򰡺 'Ƽ' ๰ ߳ ϸ(AUC), ְ߳(Cmax), û(CL/F), ְ߳(Cmax) PKǥ. ۿ ๰ ̻ Ȱ¡, ֿ ˻ġ, ȭ 򰡺 ߴ.

̹ ϵ Ʈ 4 74 ڸ ϰ, ƴ. ̴ ߼ Ḧ յ ܰ.

̹ 'Ƽ' ȭ ຸ 򰡹޴´. Ʈ FDA ž㰡û(NDA) ؾ ϴ ๰ȣۿ ͸ غϸ鼭 'Ƽ' 㰡û Ÿ´ٴ м̴.

'Ƽ' 2015 ѹ̾ǰ Ʈ pan-HER2 ׾. Ʈ ѱ, ߱ 'Ƽ' , ȭ Ǹ Ѱܹް, Ҽ , , Ű汳 پ Ȱ ɼ Ž Դ.

'Ƽ' ӻ Ȯ ZENITH20 ۷ι 2ӻ ȣƮ2 ٰŷ 븮 ܰ.

ZENITH20 ȣƮ2 HER2 (exon) 20 ̸ ϰ ๰ġ ִ Ҽ(NSCLC) ȯ 90 Ѵ. Ʈ 'Ƽ' 16mg 1 1ȸ ϰ ϰ 8.3(߾Ӱ) (ORR) 27.8% Ȯߴ. ӱⰣ 5.1(߾Ӱ), Ⱓ 5.5(߾Ӱ)̾. ๰ ̻ ƼνŰ(TKI) ̰ ٴ .

Ʈ 濵 ȣƮ2 ٰŷ FDA ÿ ǻ縦 Ȯϰ, ž㰡û(NDA) ϰڴٴ ȹ ȭߴ. 3 ๰ġ ִ HER2 20 Ҽ ȯڿ FDA żӽɻε ޾Ҵ.

żӽɻ ϰ ġ ȯ ϱ FDA  . FDA żӽɻ Ǹ 10 ҿǴ ž㰡 ɻⰣ 6 ִ. FDA ɻ簡 ݱ 㰡 ϴٴ ̴. ZENITH20 2ӻ 6 ȣƮ 8mg 1 2ȸ ϰ ϰ ִ.

迡 Ʈ 'Ƽ' FDA 㰡 ޼ ο . Ʈ ѹ̾ǰκ Ǵٸ ž 'ѷƼ' ֱ FDAκ ̿÷Ʈ ǻ Ͽ䱸(CRL) ϸ鼭 㰡 ƴ. ۳ 10 FDA 㰡 ڷγ̷ (ڷγ19) ķ ǻ縦 ϸ鼭 㰡 ̷, ̹ FDA ǻ 䱸 ߻ϸ鼭 㰡ñ⸦ ϱ .

Ʈ 忡 'Ƽ' ߸ŷ 'ѷƼ' ȭ ȸϰڴٴ ̴. Ƽ FDA 㰡 ѹ̾ǰ ž ù ۷ι ȭ ȴ.
Ȱ (kjan@dailypharm.com) ٸ
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ֽż ݴ
  • 2021.08.09 10:02:54 |

    ѱ Ϸ OECD

    ѱ 15% ݷҺ ڽŸī Ư 2 ϴ ΰ ǥ Ź δ ʰ ִ ѳ 1 2 øµ Ʒ ޲ٰ ִ

    0 1 1
ٺ Ϲݾ ǸŰ (2024 05)
౹ 71
ǰ ְ
ѽŻ÷(10) 3,500 2,300 1,200 3,028
޾(100) 25,000 22,000 3,000 23,304
Ʒγΰ(100) 30,000 27,000 3,000 29,237
īɾ(10g) 8,000 5,500 2,500 6,472
Ľõ򿬰(5g) 5,500 4,000 1,500 5,035
Ź(4) 5,000 3,500 1,500 4,449
ڶ(20) 7,000 5,800 1,200 6,433
(10) 6,000 4,000 2,000 4,914
Ժ(10) 4,000 3,000 1,000 3,543
ڱ׸(20) 5,000 3,800 1,200 4,622
ť(10) 3,500 2,300 1,200 2,828
Ȱť(1) 1,200 1,000 200 1,140
Ǯɾ(3.3ml) 25,000 22,000 3,000 24,214
޵𿬰(10g) 7,000 5,000 2,000 6,162
öŸ(34) 13,000 10,000 3,000 12,089
뽺ī(20g) 22,000 18,000 4,000 20,358
ġ(1) 1,100 1,000 100 1,000
ӽ÷(21) 10,000 7,500 2,500 8,998
ͺ(10) 3,500 2,300 1,200 3,138
ݿ(1ڽ) 3,000 2,500 500 2,947
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,973
߽Ÿ(120) 70,000 40,000 30,000 54,203
Źĸ(10ĸ) 3,000 2,000 1,000 2,941
Ÿ̾(120) 60,000 40,000 20,000 49,168
տ(60ĸ) 30,000 24,000 6,000 27,235
Ÿ̷ER(6) 2,500 2,500 0 2,500
ٿ(30g) 12,000 9,000 3,000 11,221
(120) 25,000 18,000 7,000 21,716
Ʒ(6) 4,000 3,000 1,000 3,509
ǽõĸ(270ĸ) 120,000 85,000 35,000 106,875
B(120) 70,000 60,000 10,000 62,308
׳(10) 3,000 2,000 1,000 2,684
6̺(10) 3,500 2,000 1,500 2,965
(60) 250,000 200,000 50,000 224,000
Ⱦ 12,000 9,000 3,000 10,494
̰źĸ(60ĸ) 25,500 22,000 3,500 23,942
Ųť(20) 5,500 4,500 1,000 4,823
λ絹÷(100) 37,000 29,000 8,000 31,878
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