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Table 2 List of investigated products

From: Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial

# Product FDA Approved Date Indication ORR BCT ORR of BCT Reference of BCT
1 Crizotinib
(Xalkori)
March 11, 2016 Metastatic NSCLC whose tumors are ROS1-positive 66.0% Paclitaxel + Carboplatin + 
Bevacizumab
35% Sandler et al.[9]
2 Atezolizumab
(Tecentriq)
May 18, 2016 Locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy 14.8% Vinflunine 9% Drugs@FDA [10]
3 Pembrolizumab
(Keytruda)
August 5, 2016 Recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy 16.0% Cetuximab 13% Vermorken et al. [11]
4 Rucaparib
(Rubraca)
December 19, 2016 Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies 54.0% Olaparib 34% Drugs@FDA [12]
5 Nivolumab
(Opdivo)
February 2, 2017 Locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy 19.6% Atezolizumab 14.8% See the result of #2
6 Avelumab
(Bavencio)
March 23, 2017 Metastatic MCC 33.0% NA   
7 Brigatinib
(Alunbrig)
April 28, 2017 Metastatic ALK-positive NSCLC who have progressed on or are intolerant to crizotinib 53.6% Alectinib 44% Drugs@FDA [13]
8 Durvalumab
(Imfinzi)
May 1, 2017 Locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy 17.0% Nivolumab 19.6% See the result of #5
9 Avelumab
(Bavencio)
May 9, 2017 Locally advanced or metastatic UC whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy 16.1% Nivolumab 19.6% See the result of #5
10 Pembrolizumab
(Keytruda)
May 18, 2017 Locally advanced or metastatic UC who are not eligible for cisplatin-containing chemotherapy 28.6% Carboplatin + Gemcitabine 36.1% Santis et al. [14]
11 Dabrafenib and Trametinib
(Tafinlar and Mekinist)
June 22, 2017 Metastatic NSCLC with BRAF V600E mutation 61.0% Paclitaxel + Carboplatin + 
Bevacizumab
35% Sandler et al. [9]
12 Nivolumab
(Opdivo)
July 31, 2017 dMMR and MSI-H metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan 28.0% TAS-102 1.6% Mayer et al. [15]
13 Pembrolizumab
(Keytruda)
September 22, 2017 Recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy 13.3% NA   
14 Nivolumab
(Opdivo)
September 22, 2017 HCC in patients who have been previously treated with sorafenib 14.3% Regorafenib 11% Bruix et al. [16]
15 Abemaciclib
(Verzenio)
September 28, 2017 Monotherapy for women and men with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting 19.7% Eribulin 11.0% Drugs@FDA [17]
16 Afatinib
(Gilotrif)
January 12, 2018 Broadened indication in first-line treatment of patients with metastatic NSCLC whose tumors have non-resistant EGFR mutations 66.0% Afatinib 50.4% FDA Drug Approvals and Databases [18]
17 Dabrafenib and Trametinib
(Tafinlar and Mekinist)
May 4, 2018 Locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and with no satisfactory locoregional treatment options 61.0% Paclitaxel + Carboplatin 16% Sosa et al. [19]
18 Pembrolizumab
(Keytruda)
June 1, 2018 Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥ 1) 14.3% Nab-paclitaxel 28.6% Alberts et al. [20]
19 Ipilimumab
(Yervoy)
July 10, 2018 Combination with nivolumab, MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan 46.0% Nivolumab 28% See the result of #12
20 Nivolumab
(Opdivo)
August 16, 2018 Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy 12.0% NA   
21 Cemiplimab-rwlc
(Libtayo)
September 28, 2018 Metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation 47.0% Panitumumab 31% Drugs@FDA [21]
22 Lorlatinib
(Lorbrena)
November 2, 2018 ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease 48.0% Atezolizumab 14% Drugs@FDA [22]
23 Pembrolizumab
(Keytruda)
November 9, 2018 HCC who have been previously treated with sorafenib 17.0% Nivolumab 14.3% See the result of #14
24 Pembrolizumab
(Keytruda)
December 19, 2018 Recurrent locally advanced or metastatic MCC 56.0% Avelumab 33.0% See the result of #6
25 Erdafitinib
(Balversa)
April 12, 2019 Locally advanced or metastatic UC, that has:
• susceptible FGFR3 or FGFR2 genetic alterations, and
• progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy
32.2% Pembrolizumab 21.0% Drugs@FDA [23]
26 Pembrolizumab
(Keytruda)
June 17, 2019 Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy 19.0% Nivolumab 12.0% See the result of #20
27 Entrectinib
(Rozlytrek)
August 15, 2019 Metastatic NSCLC whose tumors are ROS1-positive 78.0% Crizotinib 66.0% Drugs@FDA [24]
28 Pembrolizumab plus Lenvatinib
(Keytruda plus Lenvima)
September 17, 2019 Advanced endometrial carcinoma that is not MSI-H or dMMR and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation 38.3% Bevacizumab 13.5% Aghajanian et al. [25]
29 Niraparib
(Zejula)
October 23, 2019 Advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with HDR-positive status 24.0% Olaparib 34.0% Kim et al. [26]
30 Enfortumab vedotin-ejfv
(Padcev)
December 18, 2019 Adult patients with locally advanced or metastatic UC who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting 44.0% Docetaxel 10.5% Drakaki et al. [27]
31 Fam-trastuzumab deruxtecan-nxki
(Enhertu)
December 20, 2019 Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting 60.3% T-DM1 31.0% Krop et al. [28]
  1. ALK anaplastic lymphoma kinase, BRAF v-RAF murine sarcoma viral oncogene homolog B1, BRCA breast cancer susceptibility gene, CPS combined positive score, CSCC cutaneous squamous cell carcinoma, dMMR mismatch-repair deficient, EGFR epidermal growth factor receptor, FGFR fibroblast growth factor receptor, HCC Hepatocellular carcinoma, HDR homologous recombination deficiency, HER2 human epidermal growth factor receptor, HR hormone receptor, MCC merkel cell carcinoma, MSI-H microsatellite instability-high, NA not applicable, NSCLC non-small cell lung cancer, PD-1 programmed cell death receptor-1, PD-L1 programmed cell death ligand 1, ROS1 c-ros oncogene 1, SCLC small cell lung cancer, UC urothelial carcinoma