Sutent

Sutent (sunitinib) is a drug for which a variation assessment report was issued by the EMA. The report details findings from a study (A6181196) that enrolled 6 patients out of 8 screened. The study's last patient last visit was on 21 August 2017. The pediatric starting dose for sunitinib in GIST was 15 mg/m2.

Efficacy findings from the study include a median progression-free survival of 2.6 months, 5.8 months, and 9.0 months in different analyses. The objective response rate was 0%, while the stable disease rate was 50.0%. There was a correlation coefficient (R) of 0.59 between PFS and trough Total Drug plasma concentration. Mean plasma VEGF levels were 106.9 pg/mL on Day 1, 142.8 pg/mL on Day 14, and 128.2 pg/mL on Day 28. Mean VEGFR2 levels were 12379 pg/mL on Day 1, 10103 pg/mL on Day 14, and 9676 pg/mL on Day 28.

Safety data indicated that 3 patients experienced Grade 3 adverse events and 2 patients experienced Grade 4 adverse events. Specific adverse events included Grade 1 decrease in platelets (3 patients), Grade 1 anaemia (2 patients), Grade 3 platelets decreased (1 patient), and Grade 3 anaemia (1 patient). Regulatory procedures for this variation started on 30 July 2018, with the application submitted on 5 July 2018, and an opinion date of 13 December 2018.