On the 31st, Foresee Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its new three-month extended-release injectable formulation of leuprolide mesylate, CAMCEVI, for the treatment of prostate cancer. The company anticipates obtaining market approval next year and plans to commence sales in 2026.

Foresee highlighted that the NDA submission was based on the successful results of a Phase 3 clinical trial involving 144 patients with advanced prostate cancer. Each patient received one injection every three months, demonstrating both efficacy and favorable safety and tolerability. Data analysis showed that 97.9% of the participants met the primary efficacy endpoint.

Ben Chien, the founder and chairman of Foresee Pharmaceuticals, stated that following the successful U.S. launch of the six-month formulation of CAMCEVI in 2022, the application for the three-month formulation has now been submitted to the FDA. This move is part of the company’s goal to provide more treatment options for patients with advanced prostate cancer. Foresee expects to receive FDA approval next year and to launch the product in 2026. This development is projected not only to bring in new royalty and milestone revenue but also to potentially boost the sales volume and market share of the existing six-month formulation.

Foresee’s fastest-moving drug development projects are the new formulations of CAMCEVI for treating advanced prostate cancer, available in both six-month and three-month formulations. The six-month formulation has already been approved in the U.S., Canada, and European countries.

Resource (mandarin): 前列腺癌新藥新劑型 逸達向FDA申請藥證