Taiwan-based biopharmaceutical company Foresee Pharmaceuticals (TWO:6576) announced on Thursday that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate, 21mg), a ready-to-use long-acting injectable (LAI) formulation administered every three months, as a treatment for advanced prostate cancer.

The FDA approval was based on the successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with CAMCEVI ETM was demonstrated to be effective, safe, and well tolerated, with 97.9% of subjects achieving the primary efficacy endpoint.

As was the case for CAMCEVI 42mg, the company says that it anticipates the commercial launch to take place after obtaining a J-code. The commercial market access strategy established by Foresee's partner will seek to find a balance between near term uptake and the optimisation of mid/long term growth.

CAMCEVI ETM is exclusively licensed to Accord BioPharma Inc, the US specialty division of Intas Pharmaceuticals Ltd, for commercialisation in the United States.