The indication for which CHMP issued the recommendation is the following: "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."
According to the CHMP release: "The (agency) 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."
The recommendation now will be forwarded to the European Commission, which must issue a legally binding decision. However, before this can occur, Dendreon (DNDN) will be required to make two oral presentations, according to John Johnson, Dendreon's President and Chief Executive Officer. In discussing the company's European application for Provenge at the recent Bank of America Merrill Lynch 2013 Health Care Conference, Johnson noted "…they are looking for us to do oral discussions with two different panels and they have scheduled them back-to-back…." It is thought the two oral presentations will be separated by roughly 2 months. "Theyneed the time between the two panels and so they altered our timeline. But we do expect a regulatory decision in the second half of this year."
European Medicines Agency the CHMP Meeting Event Calendar for 2013:
August 19-22, Sept. 16-19, Oct. 21-24, Nov. 18-21, Dec. 16-18.
Since these decisions are reached in 67 days from initial recommendation on 6/28/13 (then we would be looking at around Sept.2nd). It appears that we will hear on August 22, but most likely on August 23rd. Otherwise we probably won’t hear until around September 19th which would be long past the 67 days when it was recommended to be reviewed.
Good question, at first was to be by now but all we got from Europe was its a good maybe. They sure don't seem to be any in more of a rush then the FDA was over here. I would guess it be after Labour Day--do they have Labor Day in Europe-I know Canada does