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Despite FDA Reservations, ODAC Votes Yes On Schering's PegIntron And GSK's Votrient

This article was originally published in The Pink Sheet Daily

Executive Summary

The panel voted 6-4 to recommend approval of the sBLA for PegIntron (peginterferon alfa-2b) for melanoma, and unanimously for Glaxo's Votrient (pazopanib) for advanced renal cell carcinoma.

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Pharma Suits And Letters, In Brief

Schering's Pegintron gets complete response letter: FDA handed Schering-Plough a complete response letter for Pegintron (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy. In early October, FDA's Oncologic Drugs Advisory Committee recommended approval of the biologic by a vote of 6 to 4, despite FDA's concern about modest improvement in relapse-free survival and no benefit in overall survival. The agency said the latter point was especially relevant given that the current standard of care - Schering's own Intron A - did show an improvement in overall survival during the clinical trials that supported its 1995 approval. Schering would not comment on any new trials or data FDA requested in the letter. Pegintron is currently approved in the U.S. for use in combination with Rebetol (ribavirin) for the treatment of chronic hepatitis C in patients three years of age and older with compensated liver disease (1"The Pink Sheet" DAILY, Oct. 5, 2009)

Pharma Suits And Letters, In Brief

Schering's Pegintron gets complete response letter: FDA handed Schering-Plough a complete response letter for Pegintron (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy. In early October, FDA's Oncologic Drugs Advisory Committee recommended approval of the biologic by a vote of 6 to 4, despite FDA's concern about modest improvement in relapse-free survival and no benefit in overall survival. The agency said the latter point was especially relevant given that the current standard of care - Schering's own Intron A - did show an improvement in overall survival during the clinical trials that supported its 1995 approval. Schering would not comment on any new trials or data FDA requested in the letter. Pegintron is currently approved in the U.S. for use in combination with Rebetol (ribavirin) for the treatment of chronic hepatitis C in patients three years of age and older with compensated liver disease (1"The Pink Sheet" DAILY, Oct. 5, 2009)

GSK's Votrient Will Need To Show Efficacy Outweighs Black Box

The sixth drug approved to treat renal cell carcinoma, Votrient wins approval just two weeks after a unanimous endorsement from FDA's Oncologic Drugs Advisory Committee.

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