The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Provenge.
The indication recommended by the CHMP is as follows: Provenge is indicated for the treatment of asymptomatic or minimally symptomatic metastatic ( non-visceral ) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Provenge should only be administered by physicians experienced in the treatment of prostate cancer and in an environment where resuscitation equipment is available.
The active substance of Provenge consists of autologous peripheral blood mononuclear cells activated with prostatic acid phosphatase fused with granulocyte-macrophage colony-stimulating factor ( Sipuleucel-T ).
Provenge is an immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase ( PAP ), an antigen expressed in most prostate cancers.
Provenge is available as a dispersion for infusion ( 50 x 106 CD54+ cells/250 mL ). The recommended course of treatment is 3 doses at approximately 2-week intervals. Each dose of Provenge is preceded by a standard leukapheresis procedure approximately 3 days prior to the scheduled infusion date.
The CHMP decided that the benefits of Provenge are greater than its risks following an assessment of data, including one main study that demonstrated improved survival of patients when compared with placebo.
In general Provenge is well tolerated. The most common side effects are chills, fatigue, pyrexia, nausea, arthralgia, headache and vomiting. ( Xagena )
Source: EMA, 2013