It was announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization in the European Union (EU), 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. This positive CHMP’s recommendation follows a similar positive recommendation by the Committee for Advanced Therapy (CAT).
Mark Frohlich, Executive Vice President of Research and Development and Chief Medical Officer of Dendreon said, “We are pleased with this outcome and look forward to a final regulatory decision by the European Commission later this year.”
Provenge uses the body’s own immune system to fight prostate cancer extending a man’s life. If it is ultimately approved Provenge will technically be available to men living in the European Union. However, Dendreon will ultimately still need to build a plant in Europe as the manufacturing of the therapy or find a marketing partner to take care of that responsibility.
The CHMP will make a final recommendation to the European Commission (EC) within the coming months on the marketing authorization application for PROVENGE in the EU. A formal regulatory decision from the EC is anticipated in the second half of this year.
Joel T Nowak, M.A., M.S.W.
Does frequent and constant pelvic pain and pressure and also groin discomfort and pressure, hip pain and leg numbess and lower back pain with slow and weak urine stream and dribbling daily means that the person has prostate cancer.I ‘ve been having these symptoms for three weeks now and there not getting any better.A week before these symptoms started I had been to the hospital emergency room for having chest pain and breathing problems.The emergency doctor said that I had upper respitory infection.And he gave me antibiotics and pain medicine.I ‘ve had microscopic hematuria for seven years and I still have it today with the symptoms that i’m mentioning now.I used to sit in a hard chair everyday for 22 hours daily at my computer desk and I also before I started having these pain symptoms I got hit in my pelvis accidently and it hurt for while.I also were moving a heavy refrigerator and stove sometimes when I have to sweep behind them.And I sleep on a wire spring mattress that seems to hurt me on the sides that I lay on daily.My hip pain is also in my right buttock and inner and outer thigh and there is numbness in my right leg where the hip pain and buttock pain.Could some of these syptoms have been caused by me being hit in my pelvis or me sitting on a hard chair for about 22 hours a day at my computer desk and sleeping on a wire mattress bed daily.Or could this be prostate cancer or prostatitis.
Tracey,
What you describe could be any number of things including prostate cancer. The only way to definitively diagnosis any type of cancer including prostate cancer is through a biopsy. What you describe might also be something unrelated. I do think that it is important for you to go to your doctor immediately for an examination which should include a PSA, digital rectum exam, a cardiogram as well as general blood and urine analysis. – Joel