TAIPEI, August 28, 2025 — Foresee Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable (LAI) administered every three months for the treatment of advanced prostate cancer. This approval strengthens Foresee’s presence in androgen deprivation therapy (ADT) and underscores its commitment to advancing long-acting treatment innovations.
Science Significance
The FDA’s approval is supported by results from a Phase 3 clinical trial in patients with advanced prostate cancer. The study showed that 97.9% of patients achieved the primary efficacy endpoint, demonstrating consistent testosterone suppression to castrate levels. The treatment also exhibited a strong safety and tolerability profile, confirming its role as a reliable three-month depot therapy built on Foresee’s sustained-release technology.
Regulatory Significance
This milestone marks a major regulatory achievement for Foresee Pharmaceuticals. Approval of the three-month CAMCEVI ETM formulation validates the company’s long-acting injectable platform and expands its prostate cancer treatment franchise. The FDA decision highlights successful engagement with regulatory pathways and establishes a foundation for further oncology approvals.
Business Significance
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The approval provides Foresee with new opportunities for commercial expansion in the prostate cancer market. The addition of a three-month formulation broadens the company’s therapeutic portfolio, enhances competitive positioning, and supports both near-term adoption and long-term revenue growth. The therapy strengthens Foresee’s ability to deliver flexible treatment options tailored to physician and patient needs.
Patients’ Significance
For patients, the approval of CAMCEVI ETM offers a significant advancement in treatment convenience. With a quarterly dosing schedule, the therapy reduces the frequency of injections and clinic visits while maintaining clinical efficacy and tolerability. This improved dosing regimen enhances treatment adherence and has the potential to positively impact quality of life for individuals living with advanced prostate cancer.
Policy Significance
The approval of CAMCEVI ETM reflects broader healthcare policy objectives to improve adherence, reduce treatment burden, and deliver patient-centered care. By offering a long-acting formulation that decreases resource utilization while maintaining strong outcomes, the therapy aligns with strategies aimed at achieving cost-effective and sustainable oncology care.
Transaction Highlights
The FDA approval of CAMCEVI ETM reinforces Foresee’s scientific and commercial leadership in long-acting injectable therapies. The Phase 3 trial confirmed 97.9% efficacy with proven safety and tolerability. The three-month formulation delivers enhanced flexibility for both patients and healthcare providers, supporting improved compliance and strengthening Foresee’s oncology pipeline.
Source: Foresee Pharmaceuticals Press Release
