Table 4.
Reported allergic reactions to biotechnological substances (Oncology)
| Biologics | ROA | Feature | Author | Year | HSR % |
IR % |
ISR % |
Urticaria % |
Anaphylaxis % |
|---|---|---|---|---|---|---|---|---|---|
| Aflibercept | i.v. | Human | EMA [49], FDA [50] | 2019 | 0.3 | – | – | – | – |
| Alemtuzumab |
i.v. s.c. |
Humanized | EMA [52] | 2013 | – | 2.2–2.8 | – | 17.0 | 2.8 |
| BCCA [53] | 2015 | – | < 1.0 | 1.0 | 21.–30.0 | <1.0 | |||
| FDA [54] | 2019 | – | 92.0* | – | 16.0 | 3.0 | |||
| Frau et al. [55] | 2019 | – | 95.5* | – | – | – | |||
| Atezolizumab | i.v. | Humanized | FDA [56] | 2016 | – | 1.3–1.7 | – | – | – |
| EMA [57] | 2019 | ≤10.0 | ≤10.0 | ≥10.0 | ≤10.0 | ||||
| BCCA [58] | 2020 | ≤1.0 | <1.0 | 8.–18.0** | ≤1.0 | ||||
| Bevacizumab | i.v. | Humanized | BCCA [59] | 2016 | ≤5.0 | ≤5.0 | – | – | – |
| EMA [60] | 2019 | 2.5–5.9 | 0.3–6.1 | – | 2.5–5.9 | ||||
| FDA [61] | 2019 | – | <3.0 | – | – | ||||
| Blinatumomab | i.v. | Murine | BCCA [62] | 2017 | 2.0 | 29.0 | – | – | – |
| EMA [63] | 2018 | – | 67.2 | – | – | ||||
| FDA [64] | 2019 | – | 77.0 | – | – | ||||
| Cetuximab | i.v. | Chimeric | Needle et al. [67] | 2002 | 7.4 | – | – | – | 1.4 |
| Mariotte et al. [74] | 2011 | 15.2 | – | – | – | ||||
| Maggi et al. [65] | 2011 | – | 1.2–15.0 | – | – | ||||
| Galvão et al. [68] | 2015 | 1.1–5.0 | 15.0–21.0 | – | – | ||||
| FDA [69] | 2019 | – | 8.4 | – | – | ||||
| Durvalumab | i.v. | Human | FDA [75] | 2019 | – | 0.3–2.2 | – | 11.–26.0** | – |
| EMA [76] | 2020 | – | 0.3–1.9 | 1.6** | – | ||||
| BCCA [77] | 2020 | – | 1.0–2.0 | 14.–26.0** | – | ||||
| Gemtuzumab ozogamicin | i.v. | Humanized | FDA [78] | 2006 | 0 | 8.0 | 22.0 | – | – |
| EMA [79] | 2018 | – | 3.6–7.6 | 2.1–9.3 | 5.8–19.9** | – | |||
| Ibritumomab tiuxetan | i.v. | Mouse | FDA [81] | 2002 | 2.0 | – | – | 4.0 | <1.0 |
| EMA [82] | 2017 | <10.0 | – | – | – | <1.0 | |||
| BCCA [83] | 2017 | <1.0 | 1.0 | 1.0–13.0 | – | 1.0–5.0 | |||
| Ipilimumab | i.v. | Human | FDA [87] | 2019 | – | 4.2–5.1 | – | 2.0 | – |
| EMA [88] | 2020 | <1.0 | 2.2–4.0 | 1.0–10.0 | 0.1–0.01 | ||||
| BCCA [89] | 2020 | – | 2.0–6.0 | 19.–26.0** | – | ||||
| Necitumumab | i.v. | Human | FDA [91] | 2015 | – | 1.5 | – | – | – |
| EMA [92] | 2016 | – | 1.5 | – | 2.8 | ||||
| Nivolumab | i.v. | Human | FDA [93] | 2019 | – | 6.4 | – | – | – |
| EMA [94] | 2020 | 1.–10.0 | 1.–10.0 | 17.–65.0** | 0.1–0.01 | ||||
| BCCA [95] | 2020 | – | 2.0–4.0 | 1.0 | – | ||||
| Panitumumab | i.v. | Human | FDA [100] | 2015 | – | 1.0–4.0 | – | – | – |
| BCCA [101] | 2020 | 1.0 | 3.0–4.0 | – | 1.0 | ||||
| Pembrolizumab | i.v. | Humanized | EMA [103] | 2019 | – | 1.–10.0 | – | 1.5** | – |
| BCCA [104] | 2019 | – | <1.0 | – | – | ||||
| FDA [105] | 2020 | 0.2 | 0.2 | – | 0.2 | ||||
| Pertuzumab | i.v. | Humanized | BCCA [107] | 2014 | 11.0 | 13.–19.0 | – | – | – |
| EMA [108] | 2019 | 1.–10.0 | ≥10.0 | – | 0.1–1.0 | ||||
| FDA [109] | 2020 | 5.–11.0 | 13.–21.0 | – | 5.–11.0 | ||||
| Ramucirumab | i.v. | Human | BCCA [110] | 2017 | – | 1.–16.0 | – | – | – |
| FDA [111] | 2019 | – | 1.–9.0 | – | – | ||||
| EMA [112] | 2019 | – | <10.0 | – | – | ||||
| Trastuzumab |
i.v. s.c. |
Humanized | BCCA [113] | 2020 | 3.0 | 21.0–40.0 | – | – | – |
| Galvão et al. [68] | 2015 | 0.6–5.0 | 40.0 | – | – | – | |||
| EMA [114] | 2018 | 0.9–3.5 | 8.5–37.1 | – | – | 0–0.9 | |||
| FDA [115] | 2019 | 2.2–2.7 | 1.4–1.6 | – | – | <1.0 |
ROA route of administration, HSR hypersensitivity reaction, IR infusion reaction, ISR Injection-site reaction, s.c. subcutaneous, i.v. intravenous, FDA Food and Drug Administration, EMA European Medicines Agency, BCCA British Columbia Cancer Agency
*mild to moderate or any grade of reaction when intravenously administered
**immune-mediated rash