FDA Approves Foresee's CAMCEVI ETM 21mg for Advanced Prostate Cancer Treatment
Key Insights
The FDA has approved CAMCEVI ETM (search) (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable formulation administered every 3 months for advanced prostate cancer (search) treatment.
The approval was based on a successful Phase 3 clinical study with 144 advanced prostate cancer (search) patients, demonstrating 97.9% of subjects achieved the primary efficacy endpoint.
CAMCEVI ETM (search) is exclusively licensed to Accord BioPharma (search) for U.S. commercialization, with commercial launch expected after obtaining a J-code.
Foresee Pharmaceuticals (search) announced that the U.S. Food and Drug Administration has approved the New Drug Application for CAMCEVI ETM (search) (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable formulation administered every 3 months for the treatment of advanced prostate cancer (search). The approval, granted on August 25, 2025, marks a significant milestone for the Taiwan and U.S.-based biopharmaceutical company.
"The approval of CAMCEVI ETM (search) (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients," said Dr. Ben Chien, founder, Chairman, and CEO of Foresee. "It is also a key step in our efforts to build Foresee as a profitable and growing business."
Clinical Trial Results Drive Approval
The FDA approval was based on a successful Phase 3 clinical study that enrolled 144 advanced prostate cancer (search) patients. The trial demonstrated that treatment with CAMCEVI ETM (search) was effective, safe, and well tolerated, with 97.9% of subjects achieving the primary efficacy endpoint. This high success rate underscores the therapeutic potential of the long-acting injectable formulation.
Commercial Strategy and Market Access
CAMCEVI ETM (search) is exclusively licensed to Accord BioPharma (search), Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. for commercialization in the United States. Following the pattern established with CAMCEVI 42 mg, the commercial launch is anticipated to take place after obtaining a J-code, which is necessary for reimbursement and market access.
The commercial market access strategy established by Foresee's partner aims to balance near-term uptake with optimization of mid and long-term growth potential in the advanced prostate cancer (search) treatment market.
Expanding Treatment Portfolio
This approval represents Foresee's second FDA-approved treatment for advanced prostate cancer (search). CAMCEVI 42 mg was previously approved and launched in the U.S. in April 2022, and is now approved in multiple markets including the U.S., Canada, EU, Taiwan, Israel, and the UK.
The company's product development strategy centers on its unique Stabilized Injectable Formulation (SIF) long-acting injectable technology, which enables extended dosing intervals that may improve patient compliance and quality of life.
Broader Pipeline Development
Beyond prostate cancer, Foresee is developing CAMCEVI formulations for additional indications. The company is conducting the Casppian Phase 3 clinical study for CAMCEVI 6-month LAI formulation in central precocious puberty (search) (CPP). Additionally, a Phase 3 clinical trial is ongoing in China for premenopausal breast cancer (search) in collaboration with a partner.
The company's research and development efforts extend beyond its SIF technology to include first-in-class new chemical entity programs targeting rare and severe diseases with high unmet medical needs. These include aderamastat (FP-025), a highly selective oral MMP-12 (search) inhibitor that completed Phase 2 proof-of-concept studies in allergic asthmatic patients, and mirivadelgat (FP-045), an oral small molecule allosteric activator of ALDH2 (search) currently in Phase 2 development for pulmonary hypertension-interstitial lung disease (search).