Table 1 Maximum tolerated doses of approved drugs in Japan, US, and EU
From: Impact of race on dose selection of molecular-targeted agents in early-phase oncology trials
Name of drug (references) | RP2D (Japan) | RP2D (Western) | Concordance (Phase I) | PMDA approved dose and date | FDA or EMA approved dose and date | Concordancea (approved) | Delay in approval in Japan (years) |
|---|---|---|---|---|---|---|---|
Gefitinib | 250 and 500 mg | 250 and 500 mg | Concordant | 250 mg QD 7/5/2002 | 250 mg QD 5/5/2003 | Concordant | −0.8 |
Erlotinib | 150 mg QD | 150 mg QD | Concordant | 150 mg QD 10/19/2007 | 150 mg QD 11/18/2004 | Concordant | 2.9 |
Sorafenib | 400 mg BID | 400 mg BID | Concordant | 400 mg BID 1/25/2008 | 400 mg BID 12/20/2005 | Concordant | 2 |
Sunitinib | 50 mg QD | 50 mg QD | Concordant | 50 mg QD 4/16/2008 | 50 mg QD 1/26/2006 | Concordant | 2.1 |
Crizotonib | 250 mg BID | 250 mg BID | Concordant | 250 mg BID 3/20/2012 | 250 mg BID 8/26/2011 | Concordant | 0.5 |
Axitinib | 5 mg BID | 5 mg BID | Concordant | 5 mg BID 6/29/2012 | 5 mg BID 1/27/2012 | Concordant | 0.4 |
Pazopanib | 800 mg or 1000 mg QD | 800 mg QD | Concordant | 800 mg QD 9/28/2012 | 800 mg QD 10/19/2009 | Concordant | 2.9 |
Regorafenib | 160 mg QD | 160 mg QD | Concordant | 160 mg QD 3/25/2013 | 160 mg QD 9/27/2012 | Concordant | 0.5 |
Afatinib | 50 mg QD | 50 mg QD | Concordant | 40 mg QD 1/17/2014 | 40 mg QD 7/12/2013 | Concordant | 0.5 |
Vemurafenib | 960 mg BID | 960 mg BID | Concordant | 960 mg BID 12/26/2014 | 960 mg BID 8/17/2011 | Concordant | 2.3 |
Lenvatinib | 24 mg QD | 25 mg QD | Concordant | 24 mg QD 3/26/2015 | 24 mg QD 2/13/2015 | Concordant | 0.1 |
Vandetanib | 300 mg QD | 300 mg QD | Concordant | 300 mg QD 9/28/2015 | 300 mg QD 4/6/2011 | Concordant | 4.5 |
Ceritinib | 750 mg QD | 750 mg QD | Concordant | 750 mg QD 3/28/2016 | 750 mg QD 4/29/2014 | Concordant | 1.9 |
Lapatinib | 1500 mg QD | 1250 mg QD | Different | 1250 mg QD 4/22/2009 | 1250 mg QD 3/13/2007 | Concordant | 2 |
Everolimus | 10 mg QD | 5 or 10 mg QD or 20–50 mg weekly | Different | 10 mg QD 1/20/2010 | 10 mg QD 3/30/2009 | Concordant | 0.8 |
Temsirolimus | 15 mg/m2 weekly | Weekly doses of 25, 75, and 250 mg | Different | 25 mg weekly 7/23/2010 | 25 mg weekly 5/30/2007 | Concordant | 3.1 |
Osimertinib | Not done | 80 mg QD | NA | 80 mg QD 3/28/2016 | 80 mg QD 11/13/2015 | Concordant | 0.3 |
