What is zolbetuximab’s extravasation risk classification?

Published

Zolbetuximab’s extravasation risk is unclassified

Local tolerance at injection sites was assessed in mice for 13 weeks and in cynomolgus monkeys for 4 weeks, with no reactions related to zolbetuximab observed during daily macroscopic or histopathological evaluations.1 

  • In the SPOTLIGHT and GLOW Phase 3 trials, extravasation occurred in 0.9% (10/1060) of all patients.1 Four out of the ten cases reported were attributed to concomitant chemotherapy agents (fluorouracil or oxaliplatin), with no cases reported by investigators as related to zolbetuximab.
  • The SPOTLIGHT and GLOW clinical trial protocols did not provide guidance on management of extravasation specifically for zolbetuximab.2,3

  1. Data on File.

  2. Shitara K, Lordick F, Bang YJ, et al. Supplement to Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655-1668. Available at: https://doi.org/10.1016/s0140-6736(23)00620-7.

  3. Shah MA, Shitara K, Ajani JA, et al. Supplement to Zolbetuximab plus CAPOX in CLDN18.2- positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat. Med. 2023;29(8):2133-2141. Available at: https://doi.org/10.1038/s41591-023-02465-7.

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