- April 27 - 29, 2021
- 1:00 PM - 5:30 PM ET
|CDER||April 27, 2021
April 28, 2021
April 29, 2021
|1:00 p.m. to 3:45 p.m. EST
9 a.m. to 3 p.m. EST
9 a.m. to 5:30 p.m. EST
|Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.|
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
The committee will hear updates on certain supplemental biologics license applications (sBLAs) approved under 21 CFR 601.40 (subpart E, accelerated approval regulations) with confirmatory trial(s) that have not verified clinical benefit. These updates will provide information on: (1) the status and results of confirmatory clinical studies for a given indication; and (2) any ongoing and planned trials. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. Based on the updates provided, the committee will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted.
On April 27, 2021, the committee will receive updates on the following product: BLA 761034/S-018, for TECENTRIQ (atezolizumab), submitted by Genentech, Inc., indicated in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells (IC) of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.
On April 28, 2021, the committee will receive updates on the following products: (1) BLA 125514/S-017, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy; and (2) BLA 761034/S-001, trade name TECENTRIQ (atezolizumab), submitted by Genentech, Inc., indicated for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
On April 29, 2021, the committee will receive updates on the following products: (1) BLA 125514/S-024, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; (2) BLA 125514/S-042, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; and (3) BLA 125554/S-041, trade name OPDIVO (nivolumab), submitted by Bristol-Myers Squibb Company, indicated as a single agent for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
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 April 26, 2021. Submit either electronic or written comments on this public meeting by April 26, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 26, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 26, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Comments received on or before April 20, 2021 will be provided to the committee. Comments received after that date but by April 26, 2021 will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows:
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2020-N-1440 for “Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Please call 240-402-7500 ahead of the meeting time to verify access.
- Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Oral presentations from the public will be scheduled from approximately 2:55 p.m. to 3:15 p.m. Eastern Time on April 27, 2021. Oral presentations from the public will also be scheduled between approximately 10:55 a.m. to 11:15 a.m., and 2:10 p.m. to 2:30 p.m. Eastern Time on April 28, 2021. Oral presentations from the public will also be scheduled between approximately 10:50 a.m. to 11:10 a.m., 1:55 p.m. to 2:15 p.m., and from 4:40 p.m. to 5 p.m. Eastern Time on April 29, 2021. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 12, 2021.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 13, 2021.
CDER plans to provide a free of charge, live webcast of the April 27-29, 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.
- Joyce Yu, PharmD and Takyiah Stevenson, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).