# | 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 12Â 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 12Â 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 | Â | Â |
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 12Â 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 12Â 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 | Â | Â |
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 | Â | Â |
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] |