Shots:

• The approval is based on P-III CHANGE II study assessing extreme regimen (ERBITUX + cisplatin + 5-FU- followed by ERBITUX as maintenance therapy) vs Pt. based CT (cisplatin + 5-FU) in 243 patients aged ≥18 yrs. with R/M SCCHN- prior not treated with any systemic therapy in China
• The P-III CHANGE II study results: improvement in PFS (5.5 vs 4.2mos.); OS (10.2 vs 8.4mos.)- ORR (50% vs 27%) with no new safety findings
•  ERBITUX is an IgG1 mAb targeting the EGFR and is an approved therapy in 100+ countries for RAS wild-type m-CRC and for HNSCC

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 Ref: Merck | Image: Merck