The FDA has approved a 3-month injectable formulation of leuprolide mesylate (Camcevi 21 mg) for advanced prostate cancer, adding a less frequent dosing option to the workhorse GnRH-agonist class. Approval rested on the phase 3 FP-001 trial in 144 patients, which showed the formulation keeps testosterone suppressed to castrate levels in about 98% of men.
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