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Anti-PD-1 MAb approvals in US and Europe
Overview of Anti-PD-1 MAb approvals in US and Europe
Overview of Anti-PD-1 MAb approvals in US and Europe
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Anti-PD-1 MAb approvals in US and Europe |
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Date |
Region |
Therapy |
Indication |
Notes |
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Opdivo (Bristol-Myers Squibb/Ono) anti PD-1 monoclonal antibody |
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27 Nov 2015 |
US |
Monotherapy |
1st-line Braf-positive melanoma |
Complete response letter |
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24 Nov 2015 |
US |
Monotherapy |
2nd-line renal cell carcinoma |
First anti-PD1 to show OS benefit in renal cancer |
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24 Nov 2015 |
US |
Monotherapy |
1st-line Braf-W/T melanoma |
Checkmate-066 study |
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9 Oct 2015 |
US |
Monotherapy |
2nd-line non-squamous NSCLC |
Checkmate-057 study |
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1 Oct 2015 |
US |
Yervoy combo |
1st-line Braf-W/T melanoma |
First I-O combo in cancer; Checkmate-069 study |
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20 Jul 2015 |
EU |
Monotherapy |
2nd-line squamous NSCLC |
– |
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19 Jun 2015 |
EU |
Monotherapy |
1st & 2nd-line melanoma regardless of Braf status |
Checkmate-066 & 037 studies |
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4 Mar 2015 |
US |
Monotherapy |
2nd-line squamous NSCLC |
Checkmate-017 study |
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22 Dec 2014 |
US |
Monotherapy |
2nd-line melanoma |
First US approval; Checkmate-037 study |
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Keytruda (Merck & Co) anti PD-1 monoclonal antibody |
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2 Oct 2015 |
US |
Monotherapy |
2nd-line PD-L1-positive NSCLC |
Keynote-001 study |
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22 Jul 2015 |
EU |
Monotherapy |
1st & 2nd-line melanoma regardless of Braf status |
Keynote-001, 002 & 006 studies |
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4 Sep 2014 |
US |
Monotherapy |
2nd-line melanoma |
First anti-PD-1 agent to get US approval; Keynote-001 study |
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