Camcevi ETM (leuprolide 21mg 3-month depot) / Foresee Pharma, Intas, GeneScience - LARVOL DELTA

Foresee Pharmaceuticals Welcomes Positive CHMP Opinion Recommending Approval of CAMCEVI 21mg, 3-month strength in the European Union for Advanced Prostate Cancer (PRNewswire) - "A final decision regarding marketing authorization is expected in the second quarter of 2026."

CHMP • EMA approval • Prostate Cancer

Foresee Pharmaceuticals…announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI) formulation administered every 3 months), as a treatment for advanced prostate cancer. (PRNewswire) - "The FDA approval was based on the successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with CAMCEVI ETM was demonstrated to be effective, safe, and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint."

FDA approval • Prostate Cancer

Foresee Pharmaceuticals Announces the PDUFA Goal Date for the 3-month Version of CAMCEVI is August 29, 2025 (PRNewswire) - "Foresee Pharmaceuticals...announces that the U.S. Food and Drug Administration (FDA) issued a Day-74 letter. The Day-74 letter states that the PDUFA goal date for a decision on marketing approval for the 3-month version of CAMCEVI (leuprolide mesylate 21 mg, 3-month long-acting injectable (LAI) formulation) for the treatment of adult patients with advanced prostate cancer is August 29, 2025....The NDA submission for the 3-month version of CAMCEVI is supported by a previously communicated successful Phase 3 clinical study with a total of 144 advanced prostate carcinoma patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint."

PDUFA • Prostate Cancer

Foresee Pharmaceuticals Announces Submission of the NDA to the U.S. FDA for the 3-month Version of CAMCEVI for the Treatment of Advanced Prostate Cancer (PRNewswire) - "Foresee Pharmaceuticals...announced today that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer. This NDA submission is supported by a previously successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint....'We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026'..."

FDA approval • FDA filing • Launch US • Prostate Cancer