Erbitux approved in China for head and neck cancers

2 March 2020

German pharma and sciences firm Merck KGaA (MRK: DE) says that its Erbitux (cetuximab) has been granted approval by China’s National Medical Products Administration (NMPA) for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in combination with platinum-based therapy with fluorouracil.

Evidence from the pivotal Phase III CHANGE II study, on which the approval is based, shows the efficacy and safety of the EXTREME regimen (Erbitux + cisplatin + 5-FU, followed by Erbitux maintenance) versus platinum-based chemotherapy (cisplatin + 5-FU) alone for first-line treatment in Chinese patients with R/M SCCHN. The data showed that the addition of Erbitux to platinum-based chemotherapy improved progression-free survival (PFS), overall survival (OS) and overall response rate (ORR), confirming the relevance of the EXTREME regimen specifically in this patient population.1

‘Important development for Chinese patients’

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