European Medicines Agency Recommends Granting Marketing Authorisation for Sipuleucel-T

Recommendation concerns 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

On 27 June 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product sipuleucel-T (Provenge) to Dendreon UK Ltd. This recommendation will now be forwarded to the European Commission, which will issue a legally binding decision.

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.”

Sipuleucel-T 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). It is an immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.

Sipuleucel-T will be 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 sipuleucel-T is preceded by a standard leukapheresis procedure approximately 3 days prior to the scheduled infusion date.

The CHMP decided that the benefits of sipuleucel-T 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 sipuleucel-T is well tolerated. The most common side effects are chills, fatigue, pyrexia, nausea, arthralgia, headache and vomiting.

A pharmacovigilance plan for sipuleucel-T will be implemented as part of the marketing authorisation.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP has recommended granting a marketing authorisation for sipuleucel-T, which is considered as a new advanced-therapy medicinal product (ATMP). ATMPs are innovative medicines that are derived from gene therapy, cell therapy or tissue engineering. The CHMP recommendation follows the draft opinion of the Committee for Advanced Therapies (CAT), the Agency’s expert committee for ATMPs.

Sipuleucel-T is the fourth ATMP which has been recommended for marketing authorisation by the CHMP since the legislation on advanced therapies became operational. Sipuleucel-T has been shown to improve the overall survival by 4.1 months over placebo in clinical trial. Because it is an immunotherapy it is considered less toxic than the therapies currently available for this indication. 

The CHMP and CAT have worked closely together in the evaluation process for sipuleucel-T. Both committees have distinct responsibilities in the approval process of advanced-therapy medicines. The CAT adopts a draft opinion, which is taken into account by the CHMP when giving its recommendation regarding the authorisation of a medicine in view of the balance of benefits and risks identified.

The marketing-authorisation holder for sipuleucel-T is Dendreon. The applicant received scientific advice from the CHMP which pertained to quality and clinical aspects of the dossier.

The CHMP opinion on sipuleucel-T will now be sent to the European Commission for adoption of a marketing-authorisation decision.