Trelstar 22.5mg approved for palliative treatment of prostate cancer
TRELSTAR (triptorelin pamoate) 22.5mg injectable suspension from Watson
The FDA has approved Trelstar 22.5mg (triptorelin pamoate for injectable suspension, from Watson) for the palliative treatment of advanced prostate cancer. Trelstar 22.5mg is a GnRH analogue intended for twice-yearly administration. This approval was based on data from a Phase 3, 12-month study demonstrating that Trelstar 22.5mg produced a mean testosterone serum level of 12.8ng/dL from month 2–12. By day 29, 97.5% of patients achieved castrate level, and >98% of all patients were below castrate level at month six and month 12. Median prostate specific antigen (PSA) was also reduced by 96.4% at the end of the study.
Trelstar 22.5mg is expected to be available in May 2010.