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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the September 2, 2009 Meeting of the Oncologic Drugs Advisory Committee

 

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Morning Session

 

FDA

 

Disclaimer

 Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).

 

FDA Briefing Material (pdf)

Errata to FDA Briefing material (pdf)

 

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GLOUCESTER PHARMACEUTICALS, INC.

 

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

ISTODAX (romidepsin) Injection, proposed indication for the treatment of cutaneous T-cell lymphoma (CTCL), a form of cancer that arises in cells located in the skin, including relief of pruritus (itching), in patients who have received at least one prior systemic therapy.

(pdf)

 

 

 

Afternoon Session

 

FDA

 

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).

 

FDA Briefing Material (pdf)

Errata to FDA Briefing Material (pdf)

 

 ***************

 

 

ALLOS THERAPEUTICS, INC.

 

Disclaimer

 

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

FOLOTYN (pralatrexate) Injection, with a proposed indication for the treatment of patients with relapsed or refractory (recurring and/or not responsive to other treatments) peripheral T-cell lymphoma (PTCL), a form of cancer that develops from cells in the body known as T-cells.

(pdf)