CAMCEVI

 

Category: Pharmaceutical

Exhibitor: FORESEE PHARMACEUTICALS CO., LTD.

Booth No: M326

 

Characteristic

 

CAMCEVI® 42 mg, the 6-month depot formulations, for the treatment of advanced prostate cancer, has been approved in the U.S., Canada, the EU, Taiwan, Israel and the UK, and has been officially launched in the U.S. and Germany in April 2022 and January 2025, respectively, and the regulatory submissions are under review or under preparation in other key territories. CAMCEVI® 21 mg, the 3-month depot formulations, had the results of the Phase 3 clinical trial published in February 2019, with the primary efficacy endpoint achieved in 97.9% of subjects. The U.S. NDA for CAMCEVI® 21 mg has been submitted in October 2024 and accepted for review with a PDUFA date of August 29, 2025, and the EU regulatory submission for CAMCEVI® 21 mg has been completed in March 2025.
Following the treatment of prostate cancer, the second indication of CAMCEVI® 42 mg is planned for the treatment of central precocious puberty (CPP) in children, a multinational, multicenter phase 3 clinical study in the U.S., China and Taiwan, is ongoing. GeneScience Pharmaceuticals, Foresee's licensing partner for China, has initiated a phase 3 clinical trial of FP-001 42 mg (CAMCEVI® 42 mg) in patients with premenopausal breast cancer. The trial is currently ongoing.

 

 

 

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