CHMP recommends Camcevi to treat hormone dependent prostate cancer.- Accord Biopharma
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Camcevi, from Accord BioPharma and intended for the treatment of the cancer of the prostate in adult men when the cancer is ‘hormone-dependent’, which means that it responds to treatments that reduce the levels of the hormone testosterone.
Camcevi will be available as a 42 mg prolonged-release suspension for injection. The active substance of Camcevi is leuprorelin, a gonadotropin-releasing hormone receptor analogue (ATC code: L02AE02). Leuprorelin inhibits pituitary gonadotropin secretion and suppresses testicular steroidogenesis in males. Continuous release of leuprorelin results in below-castration ( less than 50 ng/dL) levels of testosterone in males.
Camcevi is a hybrid medicine of Eligard, which has been authorised in the EU since 23 November 2003. Camcevi contains the same active substance as Eligard but is supplied as a ready-to-use drug product in contrast to Eligard, which requires pre-mixing prior to subcutaneous injection. The salt in Camcevi (leuprorelin mesilate) is also different to that in Eligard (leuprorelin acetate).
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