Foresee Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (21 mg), 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 percent of the subjects achieving the primary efficacy endpoint.

Commenting on the development, Dr. Ben Chien, Founder, Chairman, and CEO of Foresee, said, “The approval of CAMCEVI ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients. It is also a key step in our efforts to build Foresee as a profitable and growing business.”

He further added, “As it was the case for CAMCEVI 42 mg, we anticipate the commercial launch to take place after obtaining a J-code. The commercial market access strategy established by our 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 speciality division of Intas Pharmaceuticals, for commercialisation in the US.