Cabometyx(cabozantinib)

Cabometyx (cabozantinib) is a drug with significant clinical benefit, as noted in regulatory assessments. It has been approved for use, with the Marketing Authorisation Holder being Ipsen Pharma. The approval date for Cometriq capsules (a form of cabozantinib) for medullary thyroid carcinoma was March 2014.

In a pivotal Phase 3 study for renal cell carcinoma (RCC), cabozantinib was administered as a 60 mg tablet orally once daily. Discontinuation due to adverse events in this study was 10%. In a study involving epNET, the worst Grade 3 or 4 adverse event occurred in 89% of patients in the cabozantinib arm. Safety findings also indicate reduced fertility in female rats at doses of ≥1 mg/kg/day and in male rats at doses of ≥2.5 mg/kg/day. Reduced female fertility and embryo/foetal viability were observed at 1 mg/kg. In dogs, reduced testes weight and hypospermatogenesis were seen at doses >1 mg/kg/day, and reduced ovary weight at doses ≥0.2 mg/kg/day.

The first periodic safety update report submission is due 6 months following authorisation, and a PAES submission is due in September 2017. The estimated 5-year prevalence of RCC is 229,465 cases, with 50% of RCCs detected incidentally.