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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