Foresee Pharmaceuticals Co, Ltd (TPEx: 6576), a Taiwan and US-based biopharmaceutical company, announced on Tuesday that it has submitted a 505(b)(2) New Drug Application to the US Food and Drug Administration (FDA) for the three-month version of CAMCEVI, a ready-to-use three-month depot formulation of leuprolide mesylate.

The New Drug Application seeks approval for the use of CAMCEVI intended for the palliative treatment of advanced prostate cancer.

The application has been submitted based on the earlier successful phase three clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with leuprolide mesylate injection every three months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint.

Dr Ben Chien, Foresee founder and chairman, said: "Following the successful launch of CAMCEVI 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of CAMCEVI NDA to the U.S. FDA. This marks a significant milestone in our efforts to expand treatment options for patients with advanced prostate cancer. We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile."