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Table 2 FDA approvals of MTA or immuno-oncology combinations in adult solid tumors between January 2006 and June 2016 [20]

From: Approaches to modernize the combination drug development paradigm

Year of approval

Tumor type

Combinationa

Biomarker(s)

2016

RCC

Lenvatinib + everolimusb

 

2016

Breast

Palbociclib + fulvestrantb

HR positive, HER2-negative

2015

Squamous NSCLC

Necitumumab + cisplatin/gemcitabine

 

2015

Melanoma

Cobimetinib + vemurafenibb

BRAF V600 mutation

2015

Melanoma

Nivolumab + Ipilimumabb

 

2015

CRC

Ramucirumab + FOLFIRI

 

2015

Breast

Palbociclib + letrozoleb

HR positive, HER2-negative

2014

NSCLC

Ramucirumab + docetaxel

 

2014

Ovarian, fallopian tube, primary peritoneal

Bevacizumab + paclitaxel, liposomal doxorubicin or topotecan

 

2014

Cervix

Bevacizumab + paclitaxel/cisplatin or paclitaxel/topotecan

 

2014

Gastric/GE junction

Ramucirumab + paclitaxel

 

2014

Melanoma

Trametinib + dabrafenibb

BRAF V600 mutation

2012

CRC

Ziv-aflibercept + FOLFIRI

 

2012

Breast

Everolimus + exemestaneb

HR positive, HER2-negative

2012

CRC

Cetuximab + FOLFIRI

KRAS wild type

2012

Breast

Pertuzumab + trastuzumab and docetaxelb

HER2 amplified/protein overexpression

2011

SCCHN

Cetuximab + platinum/fluoropyrimidine

 

2010

Gastric/GE junction

Trastuzumab + cisplatin/fluoropyrimidine

HER2 protein overexpression

2010

Breast

Lapatinib + letrozoleb

HER2 amplified/protein overexpression and HR positive

2009

RCC

Bevacizumab + interferon-α

 

2008

Breast

Bevacizumab + paclitaxel

HER2 negative

2007

Breast

Lapatinib + capecitabine

HER2 amplified/protein overexpression

2006

Breast

Trastuzumab + AC–T

HER2 amplified/protein overexpression

2006

NSCLC

Bevacizumab + platinum-based chemotherapy

 

2006

CRC

Bevacizumab + fluoropyrimidine-based chemotherapy

 

2006

SCCHN

Cetuximab + radiation

 
  1. aExpanded indications in the same tumor type are not listed again in this table
  2. bMTA–MTA, MTA–endocrine therapy or immuno-oncology–immuno-oncology combinations
  3. AC–T doxorubicin/cyclophosphamide–paclitaxel, CRC colorectal cancer, FOLFIRI fluorouracil/leucovorin/irinotecan, GE gastro-esophageal, HR hormone receptor, MTA molecularly targeted agent, NSCLC non-small-cell lung cancer, RCC renal cell carcinoma, SCCHN squamous cell carcinoma of the head and neck