Foresee Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment of advanced prostate cancer.
“The approval of CAMCEVI® 42 mg is a significant step toward our mission in improving the standard of care and the lives of patients,” said Dr. Ben Chien, founder and Chairman of Foresee. “It also demonstrates the success of Foresee’s pioneering Stabilized Injectable Formulation (SIF) technology. We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.
The FDA approval was based on a successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI® 42 mg injection every 6 months was demonstrated to be effective, safe and well tolerated (most common adverse events listed below in ISI). The primary efficacy end point was the percentage of subjects with suppression of serum testosterone (≤50 ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat (ITT) population. The primary efficacy endpoint was successfully achieved in 97% of subjects, with mean testosterone concentration suppressed below castrate levels to 17.6 ng/dL on day 28.
CAMCEVI® 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization.
“Camcevi® 42mg is an important addition to of the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer,” Said Chrys Kokino, U.S. President Accord BioPharma specialty products.