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Provenge Gains Approval From Medicare Panel

OncLive
Published: Thursday, Mar 31, 2011

Provenge (sipuleucel-T) activating t-cells and attacking prostate cancer cellsThe federal agency that determines Medicare reimbursements this week proposed to fully cover the cost of Provenge (sipuleucel-T), marking a victory for the $93,000 prostate cancer treatment that helps pave the way for its widespread use.

The Centers for Medicare & Medicaid Services (CMS), which posted its “proposed  decision memo” on its Web site Wednesday, said it would make a final decision by June 30, after considering public comment.

Pharmaceutical industry analysts widely expect final approval, despite the agency’s reluctance to approve Provenge coverage last year.  Dendreon Corp, the Seattle, Washington-based manufacturer of the drug, said it has already obtained coverage approvals from the 15 regional Medicare contractor boards throughout the nation.

Earlier this month, Dendreon announced that the FDA has approved quadrupling of its capacity to produce the drug at its New Jersey facility from 12 to 48 workstations. Dendreon also is seeking to open plants in Los Angeles and Atlanta.

By the end of the second quarter of this year, Dendreon expects to have about 225 infusion centers ready to treat patients with Provenge. By the end of 2011, the company plans to have about 500 infusion centers operational.

Provenge, an autologous cellular immunotherapy, is custom-manufactured for each patient through the use of the person’s dendritic cells. Last April, the FDA approved the use of Provenge for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.


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