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Table 1 The list of drugs that have higher incidence of ADRs in Japanese population

From: Analysis and enhancement of risk management for ethnic differences in antineoplastic drugs in Japan

Fix date of review report

Drug name

Drug category

Indication

Comparison between Japanese and non-Japanese population

Reference

ADRsa

PKb

Feb 2010

Panitumumab

Ab

Colorectal carcinoma

NO

Low

[16]

May 2010

Temsirolimus

TKI

Renal cell carcinoma

High

NM

[17]

Jan 2011

Eribulin mesilate

Ct

Breast cancer

High

ND

[18]

Aug 2011

Fulvestrant

Hr

Breast cancer

NO

High

[19]

Mar 2012

Crizotinib

TKI

NSCLC

High

High

[20]

May 2012

Axitinib

TKI

Renal cell carcinoma

NO

ND

[21]

Aug 2012

Pazopanib hydrochloride

TKI

Soft tissue cancer

NO

ND

[22]

Mar 2013

Regorafenib

TKI

Colorectal cancer

High

Low

[23]

Apr 2013

Pertuzumab

Ab

Breast cancer

High

ND

[24]

Aug 2013

Trastuzumab emtansin

Ab

Breast cancer

NO

ND

[25]

Oct 2013

Afatinib maleate

TKI

NSCLC

High

ND

[26]

Jan 2014

Enzalutamide

Hr

Prostate cancer

NO

ND

[27]

Apr 2014

Abiraterone acetate

Hr

Prostate cancer

High

ND

[28]

Apr 2014

Cabazitaxel acetate

Ct

Prostate cancer

High

ND

[13]

Jun 2014

Nivolumab

IO

Melanoma

High

ND

[29]

Nov 2014

Vemurafenib

TKI

Melanoma

High

ND

[30]

Mar 2015

Ramucirumab

Ab

Gastric cancer

High

ND

[31]

May 2015

Ipilimumab

IO

Melanoma

High

ND

[32]

Jul 2015

Vandetanib

TKI

Medullary thyroid cancer

High

High

[33]

Aug 2015

Trabectedin

Ct

Soft tissue tumor

High

NM

[34]

Jan 2016

Dabrafenib mesilate

TKI

Melanoma

High

NM

[35]

Feb 2016

Osimertinib mesilate

TKI

NSCLC

High

ND

[36]

Mar 2016

Ceritinib

TKI

NSCLC

High

ND

[37]

Aug 2016

Pembrolizumab

IO

Melanoma

NO

ND

[38]

Jan 2017

Afliberceot Beta

Ab

Colorectal cancer

High

NM

[39]

Jul 2017

Palbociclib

TKI

Breast cancer

High

ND

[40]

Aug 2017

Avelumab

IO

Merkel cell carcinoma

High

NM

[41]

Oct 2017

Atezolizumab

IO

NSCLC

NO

NM

[42]

Nov 2017

Olaparib

TKI

Ovarian cancer

High

ND

[43]

Apr 2018

Durvalumab

IO

NSCLC

High

Low

[44]

Jul 2018

Abemaciclib

TKI

Breast cancer

High

NM

[15]

Aug 2018

Lorlatinib

TKI

NSCLC

NO

ND

[45]

Nov 2018

Ebcorfenib/ Binimetinib

TKI

Melanoma

High

ND

[46, 47]

Nov 2018

Dacomitinib

TKI

NSCLC

NO

ND

[48]

Jan 2019

Apalutamide

Hr

Prostate cancer

NO

ND

[49]

Apr 2019

Necitumumab

Ab

Squamous NSCLC

High

ND

[50]

May 2019

Entrectinib

TKI

Solid tumors

High

ND

[51]

Nov 2019

Darolutamide

Hr

Prostate cancer

NO

ND

[52]

Jan 2020

Cabozantinib malate

TKI

Renal cell carcinoma

High

High

[53]

Feb 2020

Tepotinib hydrochloride hydrate

TKI

NSCLC

High

ND

[54]

Feb 2020

Irinotecan hydrochloride hydrate (liposome injection)

Ct

Pancreatic cancer

High

ND

[55]

Feb 2020

Trastuzumab deruxtecan

Ab

Breast cancer

High

NM

[56]

May 2020

Capmatinib hydrochloride hydrate

TKI

NSCLC

High

ND

[57]

Aug 2020

Niraparib tosilate hydrate

TKI

Ovarian cancer

High

ND

[58]

  1. All information in this table was obtained from PMDA review reports
  2. Ab Antibody, Ct Cytotoxic, Hr Hormone, IO Immune oncology treatment, NSCLC non-small cell lung cancer, TKI Tyrosine kinase inhibitor
  3. a“High” means that ADRs with higher incidence in the Japanese population was observed and “NO” means such ADRs was not observed
  4. bHigh: Higher in the Japanese population, Low: Lower in the Japanese population, ND: No difference, NM: PMDA didn’t mention the comparison