On March 6, 2026 Foresee Pharmaceuticals (6576.TWO), ("Foresee") reported that it has received notification from its licensing partner, Accord Healthcare, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending granting an extension of the marketing authorization for CAMCEVI to include a new 21 mg, 3-month ready-to-use strength of the long-acting injectable formulation for the treatment of advanced prostate cancer.
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This CHMP positive opinion is a regulatory milestone for patients living with advanced prostate cancer and the healthcare providers who treat them. CAMCEVI 21 mg is a ready-to-use subcutaneous leuprolide injection that eliminates the complex, multi-step mixing procedures required by traditional therapies. By offering a convenient 3-month dosing interval, CAMCEVI 21 mg complements CAMCEVI 42 mg by providing more options for stakeholders, streamlining the administration process for clinical staff, and also enhancing patient comfort and treatment compliance.
The European Commission (EC), which has the authority to approve medicine for the European Union, will now review the CHMP recommendation. A final decision regarding marketing authorization is expected in the second quarter of 2026.
Under the partnership framework, CAMCEVI is exclusively licensed to Accord Healthcare for commercialization across the European market. The anticipated approval of the CAMCEVI 21 mg 3-month strength will build upon the commercialization of the CAMCEVI 42 mg (6-month formulation), which officially launched in Europe in 2025.
(Press release, Foresee Pharmaceuticals, MAR 6, 2026, View Source [SID1234663340])