FDA's Oncologic Drugs Advisory Committee, Soon to Meet -- On Pegintron. . . .

As we indicated back in August, the FDA Advisory Committee morning agenda is now set, for October 5, 2009:

. . . .The committee will discuss 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. . . .

8:10 a.m. | Opening Remarks

8:15 a.m. | Sponsor Presentation -- Schering Corporation

9:00 a.m. | FDA Presentation -- sBLA 103949/5153.0

9:45 a.m. | Break

10:00 a.m. | Questions to the Presenters

10:30 a.m. | Open Public Hearing

11:00 a.m. | Questions to the ODAC and ODAC Discussion

12:00 p.m. | Lunch. . . .

[Another drug candidate will be discussed at the afternoon session. . . .]

October 5, 2009, Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Parkway, Gaithersburg, Maryland. . . .

To date, no coflicts have been reported at FDA, by any ODAC member as to Schering-Plough, or Pegintron. I'll post full-text PDFs of all the background materials, as they become available -- which usually occurs about 48 hours before the committee meets.