Table 1.

Ten years of FDA approvals for the treatment of metastatic solid tumors

Drug (reference)Approval dateNumber enrolledCancer indicationGain in PFSa, moPbGain in OS, moP
Imatinib (27)2/1/02147First-line GISTN/AN/AN/AN/A
Fulvestrant (28, 29)4/25/02400/451Second-line breast0.4/20.84/0.43
Oxaliplatin (30)8/9/02Second-line colorectal2.80.00031.50.12
Oxaliplatin (30)1/9/04531First-line colorectal2.8<0.0015.6<0.001
Pemetrexed (31)2/4/04456First-line mesothelioma1.80.0012.80.020
Bevacizumab (32)2/6/04813First-line colorectal4.4<0.0014.7<0.001
Cetuximab (33)2/12/041,198Refractory colorectal1.50.00123.50.0093
Docetaxel (34)5/19/041,006Hormone-refractory prostate0.9–2.40.36–0.009
Gemcitabine (35)5/19/04266First-line breast2.80.04892.160.0002
Erlotinib (36)11/18/04731Second/third-line NSCLC0.46<0.0012<0.001
Abraxane (37)c1/7/05460Refractory breast1.40.0062.1–2.20.024–0.374
Erlotinib (38)11/2/05569First-line pancreatic0.20.0040.330.038
Sorafenib (39, 40)12/20/05903Second-line renal cell2.7<0.012.60.146
Sunitinib (41)1/26/06312Second-line GIST4.2<0.0001NR0.007 [est]
Sunitinib (42, 43)1/26/06750Advanced renal cell6<0.0014.60.051
Cetuximab (44)3/1/06424+RT in SCCHN4.70.00619.70.03
Docetaxel (45)3/22/06445First-line gastroesophageal1.9<0.0010.60.02
Topotecan (46)6/14/06364First-line cervical1.70.0142.90.017
Bevacizumab (47)6/20/06829Second-line colorectal2.6<0.00012.10.0011
Gemcitabine (48)7/14/06356Ovarian2.80.00310.70.7349
Panitumumab (49)9/27/06463Refractory colorectal0.16<0.000100.81
Bevacizumab (50)10/11/06878First-line NSCLC1.7<0.00120.003
Docetaxel (51)10/17/06358Unresectable SCCHN2.80.0074.30.02
Lapatinib (52, 53)3/17/07324Refractory breast1.9<0.0010.30.177
Temsirolimus (54)5/30/07626Advanced renal cell2.4N/A2.60.008
Ixabepilone (55, 56)10/16/07752Second-line breast1.60.00031.80.19
Sorafenib (57)11/16/07602First-line hepatocellular2.7<0.0012.8<0.001
Pemetrexed (58)9/26/081,725First-line NSCLC0NS−0.3NS
Bevacizumab (59, 60)d5/5/09215Second-line glioblastomaE
Everolimus (61, 62)5/30/09410Advanced renal cell3<0.0010.40.162
Pemetrexed (63)7/2/09663Maintenance NSCLC1.7<0.00012.80.012
Bevacizumab (64, 65)7/31/09649First-line renal cell4.8<0.00120.336
Pazopanib (66)10/19/09435Advanced renal cell5<0.0001−0.6NS
Lapatinib (67, 68)1/29/101,286With letrozole5.20.01910.113
Erlotinib (69)4/16/101,949Maintenance NSCLC0.28<0.000110.0088
Sipuleucel-T (70)4/29/10127Hormone-refractory prostate0.390.0524.50.01
Cabazitaxel (71)7/17/10755Second-line prostate1.4<0.00012.4<0.0001
Trastuzumab (72)10/20/10594Advanced gastroesophageal1.20.00022.70.0046
Eribulin (73)11/15/10762Third-line breast1.50.1372.50.041
Ipilimumab (15)3/25/11502First-line melanoma00.0062.1<0.001
Vandetanib (74)4/6/11331Advanced medullary thyroid11.1 [est]<0.001N/AN/A
Abiraterone (75)4/28/111,195Second-line prostate2<0.0013.9<0.001
Everolimus (76)5/5/11429Advanced PNET5.10.026NRN/A
Sunitinb (77)5/20/11171Advanced PNET5.9<0.001NR0.02
Vemurafenib (78)8/17/11675First-line BRAFmt melanoma3.7<0.001N/A<0.001
Crizotinib (79, 80)8/26/1182First-line ALK+ NSCLCN/AN/AN/AN/A
Cetuximab (81)11/7/11220First-line SCCHN2.3<0.0012.70.04
Axitinib (82)1/27/12723Second-line renal cell2<0.0001N/AN/A
Total patients enrolled: 29,312 (mean, 610; median, 516)Median gain: 2.15 moMedian gain: 2.16 mo

NOTE: FDA approvals in the past decade for metastatic/advanced/refractory solid tumors. Adjuvant and neoadjuvant approvals are not included. Approvals for hematologic malignancies (lymphomas, myelomas, leukemias) also are not included.

Abbreviations: ALK, anaplastic lymphoma kinase; est, estimate; N/A, not available; NR, not reached; NS, not significant; NSCLC: non–small cell lung cancer; PNET, pancreatic neuroendocrine tumor; RT, radiotherapy; SCCHN, squamous cell carcinoma of the head and neck.

  • aIn some reported as TTP.

  • bP values consider HRs and can be very significant even though no or very little difference seen in median PFS values.

  • cAbraxane = paclitaxel albumin-stabilized nanoparticle formulation.

  • dMedian response duration is 3.9 to 4.2 mo and response rate is 19.6% to 25.9%.