Vectibix(panitumumab)

Vectibix (panitumumab) received its initial marketing authorization in the EU on December 3, 2007. A Type II variation was submitted on November 4, 2014, with a variation approval date of November 10, 2011, for EMEA/H/C/000741/II/0017. The drug has been studied in an open-label, single-arm, dose-ranging Phase 1 study involving participants aged 1 to <18 years, with the first patient enrolled on March 14, 2008, and the last patient completing on March 25, 2015, across 7 centers.

In studies of panitumumab plus FOLFIRI in wild-type RAS mCRC, the objective response rate (ORR) was 58.8% (Study 20060314 vs CRYSTAL), compared to 66.3% for cetuximab plus FOLFIRI in wild-type RAS mCRC (CRYSTAL vs Study 20060314). The median progression-free survival (PFS) for panitumumab plus FOLFIRI was 11.2 months, while for cetuximab plus FOLFIRI it was 11.4 months. For panitumumab plus FOLFOX in first-line wild-type RAS mCRC with liver metastases (PLANET), the ORR was 78%. The PFS hazard ratio for panitumumab plus FOLFIRI versus panitumumab plus FOLFOX in wild-type RAS mCRC with liver metastases was 0.86. In the age 1 to <12 years group, the disease control rate (stable disease) was 60.0% (95% CI: 14.66, 94.73%), and in the age 12 to <18 years group, it was 9.1% (95% CI: 0.23, 41.28%). The objective response rate in the pediatric population was 0%.

Safety findings in the pediatric population include 12.9% of patients experiencing treatment-related serious adverse events, with 4 patients affected in total. Fatal events occurred in 6 patients (19.4%), with 4 patients in the age 12 to <18 years group and 2 patients in the age 1 to <12 years group. Five patients experienced dose-limiting toxicities (DLTs).