When did the FDA approve Provenge?

When did the FDA approve Provenge?

In April 2010, the U.S. Food and Drug Administration (FDA) approved PROVENGE (sipuleucel-T; Dendreon), an autologous cellular immunotherapy, for the treatment of patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

Is Provenge still available?

Dendreon is the maker of the first FDA-approved immunotherapy for advanced prostate cancer, sipuleucel-T (Provenge). Sipuleucel-T will remain available after the financial restructuring of the Seattle-based company, Dendreon said in the written statement.

Does Medicare pay for Provenge?

PROVENGE is covered by Medicare and by most private insurance plans. For men receiving PROVENGE, 90% of Medicare fee-for-service members have a supplement and are expected to have minimal or no out-of-pocket costs; 85% of out-of-pocket costs are less than $50.

How much does Provenge treatment cost?

Each infusion of Provenge will cost $31,000, bringing the full cost of treatment for three infusions to $93,000. As the company put it, the drug will cost about $23,000 per month of life extension, based on the Phase III study that found the drug extended life by 4.1 months.

Who qualifies PROVENGE?

PROVENGE is specifically indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Does PROVENGE lower PSA?

PROVENGE works differently from other cancer treatments, such as chemotherapy or hormone therapy. Unlike these treatments, PROVENGE may not lower your PSA level. The goal of PROVENGE treatment is not to lower PSA level, it is to extend life.

How long does PROVENGE take to work?

Provenge immunotherapy treatment typically takes one month to be administered, and is given in three intravenous infusions every two weeks.

How long do PROVENGE side effects last?

PROVENGE (sipuleucel-T) Side Effects. Most infusion-related side effects lasted 1 or 2 days. Some patients have experienced serious adverse events while taking PROVENGE.

What comes after PROVENGE?

If you have side effects from Provenge, they would probably start soon after you get the IV of the treated cells. The most common side effects are symptoms like the flu, such as fever, chills, nausea, or general aches. They should go away in about 3 days and are usually mild to moderate.

How effective is PROVENGE?

Studies have shown that in patients with metastatic prostate cancer, Provenge has allowed men to live longer with minimal side effects, and reducing the risk of death by 22.5%. Most side effects are mild to moderate and last only 1 to 2 days.

How often is PROVENGE given?

PROVENGE is administered intravenously in a three-dose schedule at approximately two week intervals. Each dose is preceded by the leukapheresis procedure approximately three days prior to the scheduled treatment, and is administered only to the patient from whom the cells were obtained.