Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies

被引：6

作者：

Harbeck, Nadia ^{[1
]}

Wang, Jessie ^{[2
]}

Otto, Gordon Philipp ^{[3
]}

Gattu, Sreekanth ^{[3
]}

Krendyukov, Andriy ^{[3
]}

机构：

[1] Univ Munich LMU, Breast Ctr, Dept Obstet & Gynecol, D-81377 Munich, Germany

[2] Sandoz Inc, Princeton, NJ 08540 USA

[3] Hexal AG, D-83607 Holzkirchen, Germany

来源：

FUTURE ONCOLOGY | 2019年 / 15卷 / 12期

关键词：

bone marrow; bone pain; cytokine; febrile neutropenia; G-CSF; granulocyte colony-stimulating factor; headache; hematopoiesis; safety; TAC chemotherapy; COLONY-STIMULATING FACTOR; INDUCED FEBRILE NEUTROPENIA; SINGLE-ADMINISTRATION PEGFILGRASTIM; CHEMOTHERAPY-INDUCED NEUTROPENIA; BREAST-CANCER; DOUBLE-BLIND; G-CSF; DAILY FILGRASTIM; FOLLICULAR LYMPHOMA; PRIMARY PROPHYLAXIS;

D O I：

10.2217/fon-2018-0878

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Aim: This analysis compares safety data for Sandoz proposed biosimilar (LA-EP2006) and reference pegfilgrastim from a Phase I pharmacokinetic/pharmacodynamic study in healthy volunteers (HVs) and two Phase III confirmatory studies in patients with breast cancer (BC; total n = 808). Patients & methods: Baseline characteristics were summarized, and event rates of bone pain and headache calculated. Results: HVs in the Phase I pharmacokinetic/pharmacodynamic study were generally younger, with lower mean body mass index, versus BC patients in PROTECT-1/-2. Bone pain was the most frequent adverse event with similar incidences with reference versus proposed biosimilar in all studies. Conclusion: No differences in adverse events were found between Sandoz proposed biosimilar and reference pegfilgrastim, notwithstanding some differences between HVs and BC patients.

引用

页码：1313 / 1322

页数：10

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