Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss biologics license application (BLA) 761209, for retifanlimab injection, submitted by Incyte Corporation. The proposed indication (use) for this product is for the treatment of adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy.
Meeting Materials
FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at: 2021 Meeting Materials, Oncologic Drugs Advisory Committee. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2020-N-1440. The docket will close on June 23, 2021. Submit either electronic or written comments on this public meeting by June 23, 2021.
Webcast Information
CDER plans to provide a free of charge, live webcast of the June 24, 2021 Oncologic Drugs Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2021 Meeting Materials, Oncologic Drugs Advisory Committee
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
Contact Information
- She-Chia Chen
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 240-402-5343
FAX: 301-847-8533
Email: ODAC@fda.hhs.gov
- FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.