Decapeptyl triptorelin pamoate: Phase III data
Top-line data from a single-arm, open-label, European Phase III trial in patients with locally advanced or metastatic prostate cancer showed that a 3-month formulation of 11.25 mg subcutaneous Decapeptyl met the co-primary endpoints of a greater proportion of patients who castrated at day 29 and a greater proportion of patients with castration maintained at day 183. Castration was defined by testosterone levels of <50 ng/dL. Ipsen could not be reached for details regarding a threshold for meeting the endpoints, but said the results are consistent with the known efficacy and safety profile of Decapeptyl when administered intramuscularly. The company said it plans to apply to add subcutaneous administration of Decapeptyl to the label of product, which is currently indicated only for intramuscular administration. ...