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  • Product Disposition Form Cd54

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Summary Basis for Regulatory Action Date April 29 2010 From Thomas Finn PhD Chair of the Review Committee BLA/ STN 125197/0 Applicant Name Dendreon Corporation Date of Submission Oct 30 2009 PDUFA Goal Date May 1 2010 Proprietary Name Established USAN Name sipuleucel-T Indication is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant hormone refractory prostate cancer.

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

The cost for intravenous suspension - is around $65,930 for a supply of 250 milliliters, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans.

On 6 May 2015, the European Commission withdrew the marketing authorisation for (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)) in the European Union (EU).

Despite a positive recommendation by the National Comprehensive Cancer Network, sipuleucel-T's complex administration, high price, and uncertainty about the reimbursement status deterred doctors from prescribing the product.

Men who started when their PSA level was lower had a median overall survival of nearly 4 years (47.7 months). These men may have received other therapies, in addition to , as prescribed by their doctor.

was discontinued in 1.5% of patients in Study 1 due to adverse events. Some patients who required central venous catheters for treatment with developed infections, including sepsis.

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

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232