FDA's ODAC Sees "Substantial Toxicity" of PegIntron®, Come Monday

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.

Pegintron ODAC Meeting on October 5, 2009: Confirmed by FDA

So the overnight UK pressers had it right. There will be a meeting, all-day on October 5, 2009:

. . . .The committee will discuss: (1) supplemental biologics license application (sBLA) 103949/5153.0, PEGINTRON (peginterferon alfa-2b) injection, manufactured by Schering Corporation. The proposed indication (use) for this product is as an adjuvant (additional) treatment for melanoma, a kind of skin cancer. The primary treatment for melanoma that is metastatic (has spread) to the lymph nodes is surgery to remove both the original cancer and lymph nodes surrounding the cancer. PEGINTRON’s proposed use is as a treatment in addition to, or as an “adjuvant,” to surgery; and (2) new drug application (NDA) 022-465, proposed trade name VOTRIENT (pazopanib) tablets, manufactured by GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer. . . .

October 5, 2009, 8:00 AM to 5:00 PM, Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Parkway, Gaithersburg, Maryland

I'll post background materials, and other details, as they become available.

Pegintron To Be Discussed At FDA's ODAC October 5, 2009 Meeting?

At least one published report of an Advisory Committee meeting to, among other matters, discuss Schering-Plough's Pegintron, for [additional] melanoma indications (and some earlier Schering-Plough hedging on that score), is out tonight:

. . . .Meeting on Glaxo Smith Kline PLC's proposed candidate Votrient, for kidney cancer. . . . and Pegintron for use in addition to surgery for melanoma at an October 5, 2009 Advisory Committee meeting. . . .

No web-agenda, or meeting materials are up, yet though. I will keep readers posted.