Posted by Michael Wonder on 02 Mar 2020
Erbitux approved for first-line use in China in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck
2 March 2020 - Approval is for Erbitux in combination with platinum-based therapy with 5-fluorouracil for the first-line treatment of R/M SCCHN.
Merck today announced that Erbitux (cetuximab) has been granted approval by the NMPA of China 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 5-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) vs platinum-based chemotherapy (cisplatin + 5-FU) alone for first-line treatment in Chinese patients with R/M SCCHN.
