The background materials for the FDA's ODAC October 5, 2009 meeting are now online (in a 29 page PDF file). And the picture is less than pretty for Schering-Plough's PegIntron® (Peginterferon Alpha-2b).
At page 20, we see that "a total of 268 patients (44%) were considered to have discontinued therapy due in part to toxicity by FDA as compared to the Applicant’s reported 33% patient discontinuation due to toxicity. . . . [And, at page 29:] The primary question raised by this application is whether there is a favorable risk-to-benefit profile for pegylated interferon-2b. . . ."
Per Reuters' reporting:
. . . .Schering-Plough's injectable drug PegIntron carries "substantial toxicity" and had no effect on overall survival in melanoma skin cancer patients undergoing surgery, U.S. Food and Drug Administration staff reviewers said in documents released on Thursday. Schering is seeking FDA approval to sell its drug, PegIntron, for use with surgery in cases where the melanoma has spread to the lymph nodes and surgery is needed to remove both the cancer and the surrounding lymph nodes. . . .
PegIntron is already approved for other uses, such as the adjuvant treatment of malignant melanoma in patients with a high risk of recurrence. Schering’s proposed indication is “Peginterferon is indicated as adjuvant treatment for patients with stage III melanoma as evidenced by microscopic, non-palpable nodal involvement.”
Even so, it seems unlikely the sought-after label exspansion will be granted, based on these background materials.
3 comments:
But, didn't Fred once say-who really knows what the FDA wants nowadays?
Maybe he'll get lucky again.
I doubt it but, these data would explain why S/P pulled the filing in the EU.
Luck?
I doubt Fred leaves very much to chance.
Salmon
I think it interesting that the materials also highlight "no survival benefit" for this indication.
As ever, Salmon is likely right -- that Fred may have som "hold cards" he isn't showing. . . .
And those would never appear in FDA Advisory Committee background materials. . . .
We shall see.
Thanks to you both!
Namaste
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