US-based biotechnology company Dendreon Corporation has received marketing authorisation from the European Commission (EC) for its prostate cancer treatment, Provenge (sipuleucel-T).
The medication is aimed at tackling prostate cancer in men who have no symptoms or are minimally symptomatic metastatic, castrate resistant, and have no immediate need for chemotherapy.
The marketing authorisation allows Dendreon to commercialise Provenge throughout the EU, in addition to Norway, Iceland and Liechtenstein.
Dendreon president and CEO John H Johnson said: "The marketing authorisation of Provenge in the EU represents an important achievement for Dendreon.
"As the first personalised immunotherapy approved for the treatment of mCRPC in Europe, Provenge may help extend the lives of appropriate prostate cancer patients."
The Institut Gustave Department of Cancer Medicine head Prof Karim Fizazi added: "With sipuleucel-T, we have the potential to create a new treatment paradigm in advanced prostate cancer, with the integration of this novel therapy to harness a patient’s own immune system to fight their cancer."
The European marketing authorisation for Provenge was determined using data from three placebo-controlled Phase III studies, which involved around 737 patients.
In addition, it was considered safe for use based on information gathered from 601 prostate cancer patients in four clinical trials and post-marketing observation.
Dendreon executive vice-president of research and development Mark Frohlich said: "This milestone demonstrates the importance of providing a new therapeutic option with a differing mechanism of action than other approved treatments for appropriate prostate cancer patients in the EU.
"We continue to enroll patients in the EU open-label study, and plan to have a presence at the upcoming European Cancer Organisation (ECCO) and European Society for Medical Oncology (ESMO) conferences."
Image: Micrograph showing prostatic acinar adenocarcinoma (the most common form of prostate cancer) Gleason pattern 4. Photo: courtesy of Wikipedia.