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.